Health Care Professional Information Sheet-All WaveLight^® Allegretto Wave^® Systems Indications

The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized^® laser-assisted
in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized^® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procedure Manuals for the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System.

As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized^® treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight^® System Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the WaveLight^® ALLEGRO Analyzer^® device for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight^® System Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries.

Clinical Data Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Hyperopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.

The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Mixed Astigmatism: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^®
Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.

The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.

Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System used in conjuction with the Wavelight ALLEGRETTO device was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized^® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.

Contraindications: LASIK treatments using the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Warnings: Any LASIK treatment with the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^®
Eye-Q Excimer Laser System is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Precautions: Safety and effectiveness of the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular disease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; residual corneal thickness after ablation of less than 250 microns increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex^®3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); corneal, lens and/or vitreous opacities including, but not limited to, cataract; iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D.

Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size.

The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional.

Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm²; epithelium of >1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye.

The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap.

Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events.

The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye
6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; uncontrolled IOP rise and retinal detachment or retinal vascular accident.

None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and
1-year postoperatively.

Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during
wavefront-guided treatments during this clinical study.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%).

The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap.

ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 – 6.5 mm and an ablation zone of 9.0 mm.

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi S.A.
3. Imitrex^® is a registered trademark Glaxo Group Limited.

The WaveLight^® FS200 Laser System

Federal (USA) law restricts this device to sale by, or on the order of, a physician.

As with any surgical procedure, there are risks associated with the use of the WaveLight^® FS200 Femtosecond Laser System. Before treating patients with this device, you should carefully review the Procedure Manual, complete the Physician WaveLight^® System Certification Course, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® FS200 Laser System is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea; in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; in the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; and in the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

The WaveLight^® FS200 delivery system is used in conjunction with a sterile disposable Patient Interface, consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation cones, intended for single use.

The WaveLight^® FS200 Laser System should only be operated by, or under the direct supervision of, a trained physician with certification in laser safety and in the use of the WaveLight^® FS200 Laser.

Contraindications: LASIK treatments are contraindicated in: Pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Flap Contraindications: Lamellar resection for the creation of a corneal flap using the WaveLight^® FS200 laser is contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: corneal edema; corneal lesions; hypotony; glaucoma; existing corneal implant; and keratoconus.

Keratoplasty Contraindications: Penetrating cut/incision (for penetrating keratoplasty) is contraindicated in: any corneal opacity adequately dense to obscure visualization of the iris; descemetocoete with impending corneal rupture; previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and corneal thickness requirements that are beyond the range of the System.

Other Considerations: The following conditions should also be considered: severe corneal thinning; subjects with pre-existing glaucoma; a history of steroid responsive rise in intraocular pressure; preoperative intraocular pressure greater than 21 mmHg in the operative eye; subjects with more than 1000 μm corneal thickness at the 9 mm peripheral zone; active intraocular inflammation; and active ocular infection.

Complications: Possible complications which may result from flap cutting include (potential complications are not limited to those included in this list): corneal edema; corneal pain; epithelial ingrowth; epithelial infection; flap de-centration; incomplete flap creation; flap tearing or incomplete lift-off; free cap; photophobia; corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates and iritis; thin- or thick flaps; flap striae; and corneal ectasia (secondary keratoconus).

Warnings: Any treatment with the WaveLight^® FS200 is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and a history of glaucoma or ocular hypertension.

We recommend discussing the following potential complications of this device with your patients:

Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approximately 1% of patients who undergo flap creation with a femtosecond laser.³ Patients respond to the use of hourly topical steroids such as Pred Forte (Allergan), and most report improvement within one week of treatment.

Peripheral Light Spectrum (PLS): Peripheral Light Spectrum is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only a small amount of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi.
3. FDA Database Research Results Feb, 05, 2009.

CAUTION:
Federal (USA) law restricts this device to the sale by or on the order of a physician.

INDICATIONS:
The AcrySof^® IQ ReSTOR^® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

WARNING / PRECAUTION:
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof^® ReSTOR^® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof^® IQ ReSTOR^® IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof^® Natural IOL and normal color vision. The effect on vision of the AcrySof^® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS^® or BSS PLUS^® Sterile Intraocular Irrigating Solutions.

ATTENTION:
Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

Click here to view the AcrySof^® IQ ReSTOR^® IOL Directions For Use (DFU)

Currently AcrySof^® IQ Toric IOL is only available in the United States.

CAUTION:
Federal (USA) law restricts this device to the sale by or on the order of a physician.

INDICATIONS:
The AcrySof^® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

WARNING / PRECAUTION:
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens; residual viscoelastics may allow the lens to rotate.

Optical theory suggest, that, high astigmatic patients (i.e. > 2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis misalignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof^® IQ Toric Cylinder Power IOLs.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof^® Natural IOL and normal color vision. The effect on vision of the AcrySof^® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS^® or BSS PLUS^® Sterile Intraocular Irrigating Solutions.

ATTENTION:
Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

Click here to view the AcrySof^® IQ Toric IOL Directions For Use (DFU)

Click here to view the AcrySof^® IQ Toric High Cylinder Power Directions For Use (DFU)

CAUTION:
Federal (USA) law restricts this device to the sale by or on the order of a physician.

INDICATIONS:
The AcrySof^® IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.

WARNING / PRECAUTION:
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof^® Natural IOL and normal color vision. The effect on vision of the AcrySof^® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45°C; use only sterile irrigating solutions such as BSS^® or BSS PLUS^® Sterile Intraocular Irrigating Solutions.

ATTENTION:
Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

Click here to view the AcrySof^® IQ IOL Directions For Use (DFU)

CAUTION:
Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS:
AcrySof^® IQ IOL (SN60WF) Posterior Chamber Intraocular Lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. These lenses are intended for placement in the capsular bag.

WARNINGS:
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Some adverse reactions that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation and secondary surgical intervention. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations.

PRECAUTIONS:
Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof^® IQ Natural IOL and normal color vision. The effect on vision of the AcrySof^® IQ Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve disease) has not been studied. Do not resterilize; do not store over 45°C; use only sterile irrigating solutions such as BSS^® or
BSS PLUS^® Sterile Intraocular Irrigating Solutions.

ATTENTION:
Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions. The long-term effects of filtering blue light and the clinical efficacy of that filtering on the retina have not been conclusively established.

Caution:
United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.

Indication:
The LenSx^® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:

• Patients must be able to lie flat and motionless in a supine position.
• Patient must be able to understand and give an informed consent.
• Patients must be able to tolerate local or topical anesthesia.
• Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:

• Corneal disease that precludes applanation of the cornea or transmission of laser light at
  1030 nm wavelength
• Descemetocele with impending corneal rupture
• Presence of blood or other material in the anterior chamber
• Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy
• Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
• Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape
• Corneal thickness requirements that are beyond the range of the system
• Corneal opacity that would interfere with the laser beam
• Hypotony or the presence of a corneal implant
• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
• History of lens or zonular instability
• Any contraindication to cataract or keratoplasty
• This device is not intended for use in pediatric surgery

Warnings:
The LenSx^® Laser System should only be operated by a physician trained in its use.

The LenSx^® Laser delivery system employs one sterile disposable LenSx^® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.

The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.

Precautions:

• Do not use cell phones or pagers of any kind in the same room as the LenSx^® Laser.
• Discard used Patient Interfaces as medical waste.

AEs/Complications:

• Capsulotomy, phacofragmentation, or cut or incision decentration
• Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
• Capsular tear
• Corneal abrasion or defect
• Pain
• Infection
• Bleeding
• Damage to intraocular structures
• Anterior chamber fluid leakage, anterior chamber collapse
• Elevated pressure to the eye

Attention:
Refer to the LenSx^® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.

 

Caution:
Federal law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert^® IOL Injector Handpiece does not perform as expected.

Indication:
The INFINITI^® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID^® AutoSert^® IOL Injector Handpiece is intended to deliver qualified AcrySof^® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper^® Tip achieves the functionality of cataract separation.
• AquaLase^® Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells.
• The INTREPID^® AutoSert^® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID^® AutoSert^® IOL Injector Handpiece is indicated for use with ACRYSOF^® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof^® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of INFINITI^® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.

When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications:
Use of the NeoSoniX^®, OZil^® torsional, U/S, or AquaLase^® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

Attention:
Refer to the directions for use for a complete listing of indications, warnings and precautions.

CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

INDICATION: The EX-PRESS^® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS^® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor’s discretion.

CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:

Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.

Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.

Patients diagnosed with angle closure glaucoma.

WARNINGS/PRECAUTIONS: The use of this device is contraindicated if one or more of the following conditions exist:

The surgeon should be familiar with the directions for use.

The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.

This device is for single use only.

MRI of the head is permitted, however not recommended, in the first two weeks post implantation.

ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

INDICATIONS AND USAGE: BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

CONTRAINDICATIONS: There are no specific contraindications to the use of BSS PLUS; however, contraindications for the surgical procedure during which BSS PLUS is to be used should be strictly adhered to.

WARNINGS: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

PRECAUTIONS: DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. Do not use additives other than BSS PLUS Concentrate Part II (20 mL) with this product. Tissue damage could result if other drugs are added to product. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which BSS PLUS was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Description: DisCoVisc^® Ophthalmic Viscosurgical Device has an intermediate cohesive/dispersive index (CDI) and can best be described as the first viscous dispersive viscoelastic and is optimized for the entire surgical procedure.

Indications: DisCoVisc^® Ophthalmic Viscosurgical Device is indicated for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and instruments during cataract extraction and IOL insertion.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: DisCoVisc^® Ophthalmic Viscosurgical Device was very well tolerated in nonclinical and clinical studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that DisCoVisc^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Description: DUOVISC^® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DUOVISC^® Viscoelastic System consists of VISCOAT^® Ophthalmic Viscosurgical Device and PROVISC^® Ophthalmic Viscosurgical Device.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Description: VISCOAT^® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: VISCOAT^® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT^® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: VISCOAT^® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Description: PROVISC^® (Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: PROVISC^® OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery.

Precautions: Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that PROVISC^® OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer, the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury.

Adverse Reactions: Postoperative inflammatory reactions such as hypotony and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended that PROVISC^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Caution: Federal law restricts this device to sale by, or on the order of, a physician.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT^® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

The PUREPOINT^® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms.
• Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma.
• Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma.
• And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions.

The FlexTip* laser probe is intended to be used with ALCON^® 532nm laser systems.

Contraindications:

• Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments.
• The infusion cannula is contraindicated for use of oil infusion.

Complications: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used.

Warnings and Precautions:

• The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
• Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
• Leaking sclerotomy may lead to post operative hypotony.
• Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm.

Attention: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings, and precautions.

*Trademarks are property of their respective owners.

Caution: Federal law restricts this device to sale by, or on the order of, a physician.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT^® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

Warnings and Precautions:

• The infusion cannula is contraindicated for use of oil infusion.
• Attach only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient's intravenous connections.
• Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information.
• Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids.
• Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye.
• Ensure proper placement of trocar cannulas to prevent sub-retinal infusion.
• Leaking sclerotomies may lead to post operative hypotony.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.

Attention: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings and precautions.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

GRIESHABER^® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER^® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Warnings and Precautions: CONSTELLATION^® Vision System

• The disposables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
• Attach only consumables supplied by Alcon to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
• Leaking sclerotomy may lead to post operative hypotony.

Warnings and Precautions: GRIESHABER^® DSP Instruments

• Potential risk from reuse or reprocessing GRIESHABER^® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.
• Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery.
• For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON^® illumination source.
• Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized.
• Use appropriate pressure supply to ensure a stable IOP.
• If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument.

Attention: Reference the device specific Directions for Use for a complete listing of indications, warnings, and precautions.

Indications for Use: The GRIESHABER^® DSP Aspheric Macular Lens is used to visualize the fundus and retinal structures during vitreoretinal surgery. It is designed as a self-retaining contact lens to allow hands-free operation.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Warnings and Precautions:

• The device may be used only by well trained physicians and personnel.
• Potential risk from reuse or reprocessing include: reduced optical quality, surface damage on the optics, and foreign particle introduction to the eye.
• The surgeon’s team has to ensure that sufficient viscous fluid is available throughout usage of the lens for continuous humidification of the cornea.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: SILIKON^® 1000 oil is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. SILIKON^® 1000 oil is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS), related CMV retinitis and other viral infections affecting the retina.

Contraindications:

• SILIKON^® 1000 oil (purified polydimethylsiloxane) is contraindicated in patients with known hypersensitivity to silicone oil.
• SILIKON^® 1000 oil is contraindicated in pseudophakic patients with silicone intraocular lenses.

Warnings/Precautions:

• Oil-induced papillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
• Do not use a vial for more than one patient.
• Discard unused portion.
• Do not admix with any other substances prior to injection.
• Do not resterilize.
• Do not use expired product.
• An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
• The use of SILIKON^® 1000 oil as a long term tamponade has not been studied and must be determined by the treating physician. SILIKON^® 1000 oil should be removed when, in the judgment of the physician, the retinal attachment would not be compromised.

Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: PERFLUORON^® (purified perfluoro-n-octane liquid) is an intraoperative tool indicated for use during vitreoretinal surgery in patients with primary or recurrent retinal detachment which is complicated by penetrating ocular trauma, giant retinal tear(s) or proliferative vitreoretinopathy (PVR).

Contraindications:

• PERFLUORON^® liquid is contraindicated for long-term use in the eye or as vitreous replacement.

Warnings:

• PERFLUORON^® liquid should not be injected directly into the vitreous, or injected simultaneously with aspiration of the vitreous, as severe intraocular damage may occur.
• At the conclusion of the surgical procedure PERFLUORON^® liquid must be COMPLETELY removed from the eye and replaced with an appropriate vitreous substitute.
• Subretinal migration or placement of PERFLUORON^® (purified perfluoro-n-octane liquid) may occur during the injection of the device (See Directions for Use).

Attention: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.

Caution
Federal (USA) law restricts this CLASS I incisional device to the sale by or on the order of a physician.

Indications
CLASS I incisional instruments are sterile, single use disposable devices intended for use during ophthalmic surgical procedures.

Precautions
Potential complications resulting from use of this blade during ophthalmic surgery include, but are not limited to: infection, tissue damage, inflammation, edema, hyphema, hypopyon, secondary surgical re-intervention, and wound leak repair.

Properly dispose of the used device in a secure sharps instrument container.

Do not reuse. Reuse may lead to wound irregularities (due to degradation of the cutting edge sharpness) and/or cross contamination between patients.

Attention
Reference the Directions for Use labeling for a complete listing of indications and precautions.

ISPAN* Perfluoropropane (C3F8) Gas Brief Statement

Description: ISPAN* Perfluoropropane (C3F8) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN* C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum) and perfluoropropene 10 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Perfluoropropane (C3F8) is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection for selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

Sulfur Hexafluoride (SF6) Gas Brief Statement

Description: ISPAN* Sulfur Hexafluoride (SF6) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, nonflammable gas. The boiling point is
-63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN* SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum) carbon tetrafluoride 100 ppm (maximum) and hydrogen fluoride 0.3 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Sulfur Hexafluoride (SF6) gas is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection of selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

*Trademarks are property of their respective owners.

Health Care Professional Information Sheet-All WaveLight^® Allegretto Wave^® Systems Indications

The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized^® laser-assisted
in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized^® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procedure Manuals for the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System.

As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized^® treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight^® System Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the WaveLight^® ALLEGRO Analyzer^® device for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight^® System Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries.

Clinical Data Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Hyperopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.

The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Mixed Astigmatism: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^®
Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.

The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.

Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System used in conjuction with the Wavelight ALLEGRETTO device was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized^® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.

Contraindications: LASIK treatments using the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Warnings: Any LASIK treatment with the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^®
Eye-Q Excimer Laser System is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Precautions: Safety and effectiveness of the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular disease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; residual corneal thickness after ablation of less than 250 microns increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex^®3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); corneal, lens and/or vitreous opacities including, but not limited to, cataract; iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D.

Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size.

The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional.

Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm²; epithelium of >1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye.

The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap.

Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events.

The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye
6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; uncontrolled IOP rise and retinal detachment or retinal vascular accident.

None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and
1-year postoperatively.

Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during
wavefront-guided treatments during this clinical study.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%).

The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap.

ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 – 6.5 mm and an ablation zone of 9.0 mm.

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi S.A.
3. Imitrex^® is a registered trademark Glaxo Group Limited.

Health Care Professional Information Sheet-All WaveLight^® Allegretto Wave^® EX500 System Indications

The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized^® laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized^® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procedure Manuals for the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System.

As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized^® treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight^® System Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the WaveLight^® ALLEGRO Analyzer^® device for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight^® System Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries.

Clinical Data Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Hyperopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.

The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Mixed Astigmatism: The WaveLight^® ALLEGRETTO WAVE^®/ ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.

The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.

Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System used in conjuction with the WaveLight ALLEGRETTO device was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized^® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.

Contraindications: LASIK treatments using the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Warnings: Any LASIK treatment with the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Precautions: Safety and effectiveness of the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular disease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; residual corneal thickness after ablation of less than 250 microns increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex^®3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); corneal, lens and/or vitreous opacities including, but not limited to, cataract; iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D.

Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size.

The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional.

Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm²; epithelium of >1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye.

The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap.

Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events.

The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; uncontrolled IOP rise and retinal detachment or retinal vascular accident.

None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and 1-year postoperatively.

Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during wavefront-guided treatments during this clinical study.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%).

The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap.

ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0—6.5 mm and an ablation zone of 9.0 mm.

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi S.A.
3. Imitrex^® is a registered trademark Glaxo Group Limited.

The WaveLight^® FS200 Laser System

Federal (USA) law restricts this device to sale by, or on the order of, a physician.

As with any surgical procedure, there are risks associated with the use of the WaveLight^® FS200 Femtosecond Laser System. Before treating patients with this device, you should carefully review the Procedure Manual, complete the Physician WaveLight^® System Certification Course, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® FS200 Laser System is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea; in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; in the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; and in the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

The WaveLight^® FS200 delivery system is used in conjunction with a sterile disposable Patient Interface, consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation cones, intended for single use.

The WaveLight^® FS200 Laser System should only be operated by, or under the direct supervision of, a trained physician with certification in laser safety and in the use of the WaveLight^® FS200 Laser.

Contraindications: LASIK treatments are contraindicated in: Pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Flap Contraindications: Lamellar resection for the creation of a corneal flap using the WaveLight^® FS200 laser is contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: corneal edema; corneal lesions; hypotony; glaucoma; existing corneal implant; and keratoconus.

Keratoplasty Contraindications: Penetrating cut/incision (for penetrating keratoplasty) is contraindicated in: any corneal opacity adequately dense to obscure visualization of the iris; descemetocoete with impending corneal rupture; previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape; and corneal thickness requirements that are beyond the range of the System.

Other Considerations: The following conditions should also be considered: severe corneal thinning; subjects with pre-existing glaucoma; a history of steroid responsive rise in intraocular pressure; preoperative intraocular pressure greater than 21 mmHg in the operative eye; subjects with more than 1000 μm corneal thickness at the 9 mm peripheral zone; active intraocular inflammation; and active ocular infection.

Complications: Possible complications which may result from flap cutting include (potential complications are not limited to those included in this list): corneal edema; corneal pain; epithelial ingrowth; epithelial infection; flap de-centration; incomplete flap creation; flap tearing or incomplete lift-off; free cap; photophobia; corneal inflammation, such as diffuse lamellar keratitis (DLK), corneal infiltrates and iritis; thin- or thick flaps; flap striae; and corneal ectasia (secondary keratoconus).

Warnings: Any treatment with the WaveLight^® FS200 is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and a history of glaucoma or ocular hypertension.

We recommend discussing the following potential complications of this device with your patients:

Transient Light Sensitivity Syndrome (TLSS): Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity was observed in approximately 1% of patients who undergo flap creation with a femtosecond laser.³ Patients respond to the use of hourly topical steroids such as Pred Forte (Allergan), and most report improvement within one week of treatment.

Peripheral Light Spectrum (PLS): Peripheral Light Spectrum is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only a small amount of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi.
3. FDA Database Research Results Feb, 05, 2009.

Caution:
Federal law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert^® IOL Injector Handpiece does not perform as expected.

Indication:
The INFINITI^® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID^® AutoSert^® IOL Injector Handpiece is intended to deliver qualified AcrySof^® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper^® Tip achieves the functionality of cataract separation.
• AquaLase^® Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells.
• The INTREPID^® AutoSert^® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID^® AutoSert^® IOL Injector Handpiece is indicated for use with ACRYSOF^® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof^® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of INFINITI^® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.

When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications:
Use of the NeoSoniX^®, OZil^® torsional, U/S, or AquaLase^® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

Attention:
Refer to the directions for use for a complete listing of indications, warnings and precautions.

Caution
Federal (USA) law restricts this CLASS I incisional device to the sale by or on the order of a physician.

Indications
CLASS I incisional instruments are sterile, single use disposable devices intended for use during ophthalmic surgical procedures.

Precautions
Potential complications resulting from use of this blade during ophthalmic surgery include, but are not limited to: infection, tissue damage, inflammation, edema, hyphema, hypopyon, secondary surgical re-intervention, and wound leak repair.

Properly dispose of the used device in a secure sharps instrument container.

Do not reuse. Reuse may lead to wound irregularities (due to degradation of the cutting edge sharpness) and/or cross contamination between patients.

Attention
Reference the Directions for Use labeling for a complete listing of indications and precautions.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Description: DisCoVisc^® Ophthalmic Viscosurgical Device has an intermediate cohesive/dispersive index (CDI) and can best be described as the first viscous dispersive viscoelastic and is optimized for the entire surgical procedure.

Indications: DisCoVisc^® Ophthalmic Viscosurgical Device is indicated for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and instruments during cataract extraction and IOL insertion.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: DisCoVisc^® Ophthalmic Viscosurgical Device was very well tolerated in nonclinical and clinical studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that DisCoVisc^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Description: DUOVISC^® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DUOVISC^® Viscoelastic System consists of VISCOAT^® Ophthalmic Viscosurgical Device and PROVISC^® Ophthalmic Viscosurgical Device.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Description: VISCOAT^® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: VISCOAT^® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT^® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: VISCOAT^® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Description: PROVISC^® (Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: PROVISC^® OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery.

Precautions: Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that PROVISC^® OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer, the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury.

Adverse Reactions: Postoperative inflammatory reactions such as hypotony and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended that PROVISC^® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Caution: Federal law restricts this device to sale by, or on the order of, a physician.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT^® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

The PUREPOINT^® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms.
• Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma.
• Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma.
• And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions.

The FlexTip* laser probe is intended to be used with ALCON^® 532nm laser systems.

Contraindications:

• Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments.
• The infusion cannula is contraindicated for use of oil infusion.

Complications: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used.

Warnings and Precautions:

• The disposables used in conjunction with ALCON® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
• Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
• Leaking sclerotomy may lead to post operative hypotony.
• Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm.

Attention: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings, and precautions.

*Trademarks are property of their respective owners.

Caution: Federal law restricts this device to sale by, or on the order of, a physician.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT^® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

Warnings and Precautions:

• The infusion cannula is contraindicated for use of oil infusion.
• Attach only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient's intravenous connections.
• Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information.
• Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids.
• Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye.
• Ensure proper placement of trocar cannulas to prevent sub-retinal infusion.
• Leaking sclerotomies may lead to post operative hypotony.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.

Attention: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings and precautions.

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

GRIESHABER^® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER^® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Warnings and Precautions: CONSTELLATION^® Vision System

• The disposables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
• Attach only consumables supplied by Alcon to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
• Leaking sclerotomy may lead to post operative hypotony.

Warnings and Precautions: GRIESHABER^® DSP Instruments

• Potential risk from reuse or reprocessing GRIESHABER^® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.
• Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery.
• For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON^® illumination source.
• Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized.
• Use appropriate pressure supply to ensure a stable IOP.
• If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument.

Attention: Reference the device specific Directions for Use for a complete listing of indications, warnings, and precautions.

Indications for Use: The GRIESHABER^® DSP Aspheric Macular Lens is used to visualize the fundus and retinal structures during vitreoretinal surgery. It is designed as a self-retaining contact lens to allow hands-free operation.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Warnings and Precautions:

• The device may be used only by well trained physicians and personnel.
• Potential risk from reuse or reprocessing include: reduced optical quality, surface damage on the optics, and foreign particle introduction to the eye.
• The surgeon’s team has to ensure that sufficient viscous fluid is available throughout usage of the lens for continuous humidification of the cornea.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: SILIKON^® 1000 oil is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. SILIKON^® 1000 oil is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS), related CMV retinitis and other viral infections affecting the retina.

Contraindications:

• SILIKON^® 1000 oil (purified polydimethylsiloxane) is contraindicated in patients with known hypersensitivity to silicone oil.
• SILIKON^® 1000 oil is contraindicated in pseudophakic patients with silicone intraocular lenses.

Warnings/Precautions:

• Oil-induced papillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
• Do not use a vial for more than one patient.
• Discard unused portion.
• Do not admix with any other substances prior to injection.
• Do not resterilize.
• Do not use expired product.
• An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
• The use of SILIKON^® 1000 oil as a long term tamponade has not been studied and must be determined by the treating physician. SILIKON^® 1000 oil should be removed when, in the judgment of the physician, the retinal attachment would not be compromised.

Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: PERFLUORON^® (purified perfluoro-n-octane liquid) is an intraoperative tool indicated for use during vitreoretinal surgery in patients with primary or recurrent retinal detachment which is complicated by penetrating ocular trauma, giant retinal tear(s) or proliferative vitreoretinopathy (PVR).

Contraindications:

• PERFLUORON^® liquid is contraindicated for long-term use in the eye or as vitreous replacement.

Warnings:

• PERFLUORON^® liquid should not be injected directly into the vitreous, or injected simultaneously with aspiration of the vitreous, as severe intraocular damage may occur.
• At the conclusion of the surgical procedure PERFLUORON^® liquid must be COMPLETELY removed from the eye and replaced with an appropriate vitreous substitute.
• Subretinal migration or placement of PERFLUORON^® (purified perfluoro-n-octane liquid) may occur during the injection of the device (See Directions for Use).

Attention: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.

ISPAN* Perfluoropropane (C3F8) Gas Brief Statement

Description: ISPAN* Perfluoropropane (C3F8) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN* C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum) and perfluoropropene 10 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Perfluoropropane (C3F8) is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection for selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

Sulfur Hexafluoride (SF6) Gas Brief Statement

Description: ISPAN* Sulfur Hexafluoride (SF6) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, nonflammable gas. The boiling point is
-63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN* SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum) carbon tetrafluoride 100 ppm (maximum) and hydrogen fluoride 0.3 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Sulfur Hexafluoride (SF6) gas is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection of selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

*Trademarks are property of their respective owners.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: SILIKON^® 1000 oil is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. SILIKON^® 1000 oil is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS), related CMV retinitis and other viral infections affecting the retina.

Contraindications:

• SILIKON^® 1000 oil (purified polydimethylsiloxane) is contraindicated in patients with known hypersensitivity to silicone oil.
• SILIKON^® 1000 oil is contraindicated in pseudophakic patients with silicone intraocular lenses.

Warnings/Precautions:

• Oil-induced papillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
• Do not use a vial for more than one patient.
• Discard unused portion.
• Do not admix with any other substances prior to injection.
• Do not resterilize.
• Do not use expired product.
• An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
• The use of SILIKON^® 1000 oil as a long term tamponade has not been studied and must be determined by the treating physician. SILIKON^® 1000 oil should be removed when, in the judgment of the physician, the retinal attachment would not be compromised.

Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: PERFLUORON^® (purified perfluoro-n-octane liquid) is an intraoperative tool indicated for use during vitreoretinal surgery in patients with primary or recurrent retinal detachment which is complicated by penetrating ocular trauma, giant retinal tear(s) or proliferative vitreoretinopathy (PVR).

Contraindications:

• PERFLUORON^® liquid is contraindicated for long-term use in the eye or as vitreous replacement.

Warnings:

• PERFLUORON^® liquid should not be injected directly into the vitreous, or injected simultaneously with aspiration of the vitreous, as severe intraocular damage may occur.
• At the conclusion of the surgical procedure PERFLUORON^® liquid must be COMPLETELY removed from the eye and replaced with an appropriate vitreous substitute.
• Subretinal migration or placement of PERFLUORON^® (purified perfluoro-n-octane liquid) may occur during the injection of the device (See Directions for Use).

Attention: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.

ISPAN* Perfluoropropane (C3F8) Gas Brief Statement

Description: ISPAN* Perfluoropropane (C3F8) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN* C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum) and perfluoropropene 10 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Perfluoropropane (C3F8) is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection for selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

Sulfur Hexafluoride (SF6) Gas Brief Statement

Description: ISPAN* Sulfur Hexafluoride (SF6) is a liquefied gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, nonflammable gas. The boiling point is
-63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN* SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum) carbon tetrafluoride 100 ppm (maximum) and hydrogen fluoride 0.3 ppm (maximum).

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indications: ISPAN* Sulfur Hexafluoride (SF6) gas is a surgical aid for use in the treatment of uncomplicated retinal detachment by pneumatic retinopexy. It is used in the form of an intravitreal injection of selected retinal breaks and to aid in resorption of subretinal fluid. Associated measures used include transconjunctival and transcleral cryotherapy and laser photocoagulation.

Contraindications: Proliferative vitreoretinopathy (PVR) greater than Stage C, then mental or physical inability to maintain the therapeutic position for 5 postoperative days, severe glaucoma with more than a minimum of field loss and a cup to disc ratio equal to or greater than 0.6; uveitis; severe peripheral retinal degeneration; and high altitude travel, include but not limited to airline travel.

Warnings: Use of Nitrous Oxide (N2O) must be stopped at least 10 minutes before gas injection to ensure an adequate postoperative bubble is achieved. Do not administer Nitrous Oxide (N2O) if a gas bubble is present.

Do not use the ISPAN* gas if the cylinder pressure is below 50 psi as the expansion performance of the gas may change resulting in elevated intraocular pressure.

Precautions: Caution should be used in eyes with angle recession, pigment dispersion syndrome, significant anterior synechiae, traumatized eyes and eyes with significant vitreous hemorrhage obscuring an adequate view of the peripheral retina.

Attention: Reference the Physician Labeling/Directions for Use for a complete listing of adverse reactions, warnings and precautions.

*Trademarks are property of their respective owners.

Caution:
United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner.

Indication:
The LenSx^® Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:

• Patients must be able to lie flat and motionless in a supine position.
• Patient must be able to understand and give an informed consent.
• Patients must be able to tolerate local or topical anesthesia.
• Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:

• Corneal disease that precludes applanation of the cornea or transmission of laser light at
  1030 nm wavelength
• Descemetocele with impending corneal rupture
• Presence of blood or other material in the anterior chamber
• Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy
• Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
• Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape
• Corneal thickness requirements that are beyond the range of the system
• Corneal opacity that would interfere with the laser beam
• Hypotony or the presence of a corneal implant
• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)
• History of lens or zonular instability
• Any contraindication to cataract or keratoplasty
• This device is not intended for use in pediatric surgery

Warnings:
The LenSx^® Laser System should only be operated by a physician trained in its use.

The LenSx^® Laser delivery system employs one sterile disposable LenSx^® Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards.

The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction.

Precautions:

• Do not use cell phones or pagers of any kind in the same room as the LenSx^® Laser.
• Discard used Patient Interfaces as medical waste.

AEs/Complications:

• Capsulotomy, phacofragmentation, or cut or incision decentration
• Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure
• Capsular tear
• Corneal abrasion or defect
• Pain
• Infection
• Bleeding
• Damage to intraocular structures
• Anterior chamber fluid leakage, anterior chamber collapse
• Elevated pressure to the eye

Attention:
Refer to the LenSx^® Laser Operator’s Manual for a complete listing of indications, warnings and precautions.

 

Caution:
Federal law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL Injector be made available in the event the AutoSert^® IOL Injector Handpiece does not perform as expected.

Indication:
The INFINITI^® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID^® AutoSert^® IOL Injector Handpiece is intended to deliver qualified AcrySof^® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper^® Tip achieves the functionality of cataract separation.
• AquaLase^® Liquefracture Device achieves the functionality for removal of residual cortical material and lens epithelial cells.
• The INTREPID^® AutoSert^® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID^® AutoSert^® IOL Injector Handpiece is indicated for use with ACRYSOF^® lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof^® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Warnings:
Appropriate use of INFINITI^® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.

When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.

Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications:
Use of the NeoSoniX^®, OZil^® torsional, U/S, or AquaLase^® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.

Attention:
Refer to the directions for use for a complete listing of indications, warnings and precautions.

Health Care Professional Information Sheet-All WaveLight^® Allegretto Wave^® EX500 System Indications

The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Statements regarding the potential benefits of wavefront-guided and Wavefront Optimized^® laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System treatment but also the care of the clinical physicians, the control of the surgical environment by those physicians, the clinical trials’ treatment parameters and the clinical trials’ patient inclusion and exclusion criteria. Although many clinical trial patients after the wavefront-guided and Wavefront Optimized^® procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, individual results may vary. You can find information about the clinical trials below and in the Procedure Manuals for the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System.

As with any surgical procedure, there are risks associated with the wavefront-guided and Wavefront Optimized^® treatment. Before treating patients with these procedures, you should carefully review the Procedure Manuals, complete the Physician WaveLight^® System Certification Course, provide your patients with the Patient Information Booklet, and discuss the risks associated with this procedure and questions about the procedure with your patients.

Indications: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is indicated to perform LASIK treatments in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 diopters (D) of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia in patients 18 years of age or older: for the reduction or elimination of myopic refractive errors up to -12.0 D of sphere with and without astigmatic refractive errors up to -6.0 D; for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; in conjunction with the WaveLight^® ALLEGRO Analyzer^® device for the reduction or elimination of up to -7.0 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.0 D of spherical component and up to 3.0 D of astigmatic component at the spectacle plane; and in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.0 D at the spectacle plane.

LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. Only practitioners who are experienced in the medical management and surgical treatment of the cornea, who have been trained in laser refractive surgery including laser system calibration and operation, may use the device as approved. Prospective patients, as soon as they express an interest in an indicated LASIK procedure and prior to undergoing surgery, must be given the WaveLight^® System Patient Information Booklet and must be informed of the alternatives for refractive correction including eyeglasses, contact lenses, PRK, and other refractive surgeries.

Clinical Data Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System was studied in clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Hyperopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

The studies found that of the 212 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5% were corrected to 20/20 or better without spectacles or contact lenses.

The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

Clinical Data Mixed Astigmatism: The WaveLight^® ALLEGRETTO WAVE^®/ ALLEGRETTO WAVE^® Eye-Q Excimer Laser System has been studied in clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%.

The studies found that of the 142 eyes eligible for the UCVA analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied.

Clinical Data Wavefront-guided Treatment of Myopia: The WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System used in conjuction with the WaveLight ALLEGRETTO device was studied in a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized^® LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

The studies found that of the 180 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point in the Study Cohort, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses.

The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months); and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort: halos (36.6% at baseline versus 45.4% at 3 months); and visual fluctuations (18.3% at baseline versus 21.9% at 3 months). Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.

Contraindications: LASIK treatments using the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System are contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list: pregnant or nursing women; patients with a diagnosed collagen vascular, autoimmune or immunodeficiency disease; patients with diagnosed keratoconus or any clinical pictures suggestive of keratoconus; and patients who are taking one or both of the following medications: isotretinoin (Accutane^®1), amiodarone hydrochloride (Cordarone^®2).

Warnings: Any LASIK treatment with the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System is not recommended in patients who have: systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; a history of Herpes simplex or Herpes zoster keratitis; significant dry eye that is unresponsive to treatment; severe allergies; and unreliable preoperative wavefront examination that precludes wavefront-guided treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment.

Precautions: Safety and effectiveness of the WaveLight^® ALLEGRETTO WAVE^® / ALLEGRETTO WAVE^® Eye-Q Excimer Laser System have not been established for patients with: progressive myopia, hyperopia, astigmatism and/or mixed astigmatism; ocular disease; previous corneal or intraocular surgery, or trauma in the ablation zone; corneal abnormalities including, but not limited to, scars, irregular astigmatism and corneal warpage; residual corneal thickness after ablation of less than 250 microns increasing the risk for corneal ectasia; pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablation planning; history of glaucoma or ocular hypertension of > 23 mmHg; taking the medication sumatriptan succinate (Imitrex^®3); under 18 years (21 years for mixed astigmatism) of age; over the long term (more than 12 months after surgery); corneal, lens and/or vitreous opacities including, but not limited to, cataract; iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eyetracking; taking medications likely to affect wound healing including, but not limited to, antimetabolites; treatments with an optical zone below 6.0 mm or above 6.5 mm in diameter; treatment targets different from emmetropia (plano) in which the wavefront-calculated defocus (spherical term) has been adjusted; myopia greater than – 12.0 D or astigmatism greater than 6 D; hyperopia greater than + 6.0 D or astigmatism greater than 5.0 D; mixed astigmatism greater than + 6.0 D; and in cylinder amounts > 4.0 to < 6.0 D.

Due to the lack of large numbers of patients in the general population, there are few subjects with cylinder amounts in this range to be studied. Not all complications, adverse events, and levels of effectiveness may have been determined.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery. Some patients may find it more difficult to see in such conditions as very dim light, rain, fog, snow and glare from bright lights. This has been shown to occur more frequently in the presence of residual refractive error and perhaps in patients with pupil sizes larger than the optical zone size.

The refraction is determined in the spectacle plane, but treated in the corneal plane. In order to determine the right treatment program to achieve the right correction, assessment of the vertex distance during refraction testing is recommended. Preoperative evaluation for dry eyes should be performed. Patients should be advised of the potential for dry eyes post LASIK and post wavefront-guided LASIK surgery. This treatment can only be provided by a licensed healthcare professional.

Adverse Events and Complications for Myopia: Certain adverse events and complications occurred after the LASIK surgery. Two adverse events occurred during the postoperative period of the clinical study: 0.2% (2/876) had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment, corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of >1 mm²; epithelium of >1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of >5 mmHg or any reading above 25 mmHg; retinal detachment or retinal vascular accident; and decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after LASIK during this clinical trial: 0.8% (7/844) of eyes had a corneal epithelial defect; 0.1% (1/844) had any epithelium in the interface; 0.1% (1/844) had foreign body sensation; 0.2% (2/844) had pain; and 0.7% (6/844) had ghosting or double images in the operative eye.

The following complications did NOT occur 3 months following LASIK in this clinical trial: corneal edema and need for lifting and/or reseating the flap/cap.

Adverse Events and Complications for Hyperopia: Certain adverse events and complications occurred after the LASIK surgery. Only one adverse event occurred during the clinical study: one eye (0.4%) had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 6 months after LASIK during this clinical trial: 0.8% (2/262) of eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

The following complications did NOT occur 6 months following LASIK in this clinical trial: corneal edema; foreign body sensation; pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Adverse Events and Complications for Mixed Astigmatism: Certain adverse events and complications occurred after the LASIK surgery. No protocol defined adverse events occurred during the clinical study. However, two events occurred which were reported to the FDA as Adverse Events.

The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. The second event involved the treatment of an incorrect axis of astigmatism which required retreatment.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; corneal epithelial defect involving the keratectomy at 1 month or later; corneal edema at 1 month or later visible in the slit lamp exam; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; lost, misplaced, or misaligned flap, or any flap/cap problems requiring surgical intervention beyond 1 month; decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; uncontrolled IOP rise and retinal detachment or retinal vascular accident.

None of the following complications occurred at 3 months after LASIK during this clinical trial: corneal edema; corneal epithelial defect; any epithelium in the interface; foreign body sensation, pain, ghosting or double images; and need for lifting and/or reseating of the flap/cap.

Subjects were asked to complete a patient questionnaire preoperatively and at 3-months, 6-months, and 1-year postoperatively.

Adverse Events and Complications for Wavefront - guided Myopia: Certain adverse events and complications occurred after the wavefront-guided LASIK surgery. No adverse event occurred during wavefront-guided treatments during this clinical study.

The following adverse events did NOT occur: corneal infiltrate or ulcer requiring treatment; lost, misplaced or misaligned flap or any flap/cap problems requiring surgical intervention beyond 1 month; corneal edema at 1 month or later visible in the slit lamp exam; any complication leading to intraocular surgery; melting of the flap of > 1 mm²; epithelium of > 1 mm² in the interface with loss of 2 lines or more of BSCVA; uncontrolled IOP rise with increase of > 5 mmHg or any reading above 25 mmHg; and decrease in BSCVA of > 10 letters not due to irregular astigmatism as shown by hard contact lens refraction.

The following complications occurred 3 months after wavefront-guided LASIK during this clinical trial: corneal epithelial defect (0.6%); foreign body sensation (0.6%); and pain (0.6%).

The following complications did NOT occur 3 months following wavefront-guided LASIK in this clinical trial: corneal edema; any epithelium in the interface; ghosting or double images; and need for lifting and/or reseating of the flap/cap.

ATTENTION: The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0—6.5 mm and an ablation zone of 9.0 mm.

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

1. Accutane^® is a registered trademark of Hoffmann-La Roche Inc.
2. Cordarone^® is a registered trademark of Sanofi S.A.
3. Imitrex^® is a registered trademark Glaxo Group Limited.