Product Information
OptiLASIK® Laser Vision Correction
Myopia:
a. Approval of the premarket approval application is for the WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System to perform LASIK treatments in patients 18 years of age or older for the
reduction or elimination of myopic refractive errors up to -12.0 diopters (D) of
sphere with and without astigmatic refractive errors up to -6.0 D; and in patients
with documented evidence of a stable manifest refraction defined as less than or
equal to 0.50 D of preoperative spherical equivalent shift over one year prior to
surgery.
b. LASIK is an elective procedure with the alternatives including but not limited
to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive
surgeries.
c. Approval of the application is based on 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%.
d. 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.
e. 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 posttreatment: visual fluctuations (12.8% at baseline
vs 28.6% at 3 months).
f. Long-term risks of LASIK for myopia with and without astigmatism beyond 12 months
have not been studied.
g. Note that the complete name for this ophthalmic laser is "WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System for laser assisted in-situ keratomileusis (LASIK) treatments of myopic refractive
errors up to -12.0 diopters (D) of sphere with and without astigmatic refractive
errors up to -6.0 D at the spectacle plane."
Hyperopia:
a. Approval of the premarket approval application is for the WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System to perform LASIK treatments in patients 18 years of age or older for the
reduction or elimination of hyperopic refractive errors up to +6.0 diopters (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;
and in patients with documented evidence of a stable manifest refraction defined
as less than or equal to 0.50 D of preoperative spherical equivalent shift over
one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
b. LASIK is an elective procedure with the alternatives including but not limited
to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive
surgeries.
c. Approval of the application is based on 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%.
d. The studies found that of the 212 eyes eligible for the uncorrected visual acuity
(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.
e. 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%).
f. Long term risks of LASIK for hyperopia with and without astigmatism beyond 12
months have not been studied.
g. Note that the complete name for this ophthalmic laser is "WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System for laser assisted in-situ keratomileusis (LASIK) treatments of hyperopic
refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic
refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent
(MRSE) of +6.0 D."
Mixed Astigmatism:
a. Approval of the premarket approval application is for the WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System to perform LASIK treatments in patients 21 years of age or older for the
reduction or elimination of naturally occurring mixed astigmatism of up to 6.00
D at the spectacle plane; and in patients with documentation of a stable manifest
refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent
shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including but not limited
to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive
surgeries.
c. Approval of the application is based on 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%.
d. The studies found that of the 142 eyes eligible for the uncorrected visual acuity
(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.
e. 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
vs 52.9% at 3 months); visual fluctuations (32.1% at baseline vs 43.0% at 3 months);
and halos (37.0% at baseline vs 42.3% at 3 months).
f. Long term risks of LASIK for mixed astigmatism beyond 6 months have not been
studied.
g. The safety and effectiveness of LASIK surgery has ONLY been established with
an optical zone of 6.0 ‐ 7.0 mm and an ablation zone of 9.0 mm.
h. Note that the complete name for this ophthalmic laser is "WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System for laser assisted in-situ keratomileusis (LASIK) treatments of naturally
occurring mixed astigmatism of up to 6.00 D at the spectacle plane."
Wavefront-Guided Treatment of Myopia:
a. Approval of the premarket approval application is for the WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System used in conjunction with the WaveLight® Analyzer device. The
device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated
for Wavefront-Guided (WFG) laser assisted insitu keratomileusis (LASIK): 1) for
the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent
myopia or myopia with astigmatism, with up to -7.00 D of spherical component and
up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who
are 18 years of age or older; and 3) in patients with documentation of a stable
manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent
shift over one year prior to surgery.
b. LASIK is an elective procedure with the alternatives including but not limited
to eyeglasses, contact lenses, photorefractive keratectomy (PRK), traditional LASIK
and other refractive surgeries.
c. Approval of the application is based on 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%.
d. The studies found that of the 180 eyes eligible for the uncorrected visual acuity
(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 uncorrected visual acuity (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.
e. 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 vs 47.8% at 3 months) and visual fluctuations (13.8% at baseline
vs 20.0% at 3 months). In the Control Cohort, halos (36.6% at baseline vs 45.4%
at 3 months) and visual fluctuations (18.3% at baseline vs 21.9% at 3 months).
f. Long term risks of Wavefront-Guided LASIK for myopia with and without astigmatism
beyond 6 months have not been studied.
g. Note that the complete name for this ophthalmic laser is "WaveLight®
Allegretto Wave®/Allegretto Wave® Eye-Q Excimer Laser
System used in conjunction with the WaveLight® Analyzer device. The
device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated
for Wavefront-Guided (WFG) laser-assisted insitu keratomileusis (LASIK): 1) for
the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent
myopia or myopia with astigmatism, with up to -7.00 D of spherical component and
up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who
are 18 years of age or older; and 3) in patients with documentation of a stable
manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent
shift over one year prior to surgery."
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.
AcrySof® IQ ReSTOR® IOL
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)
AcrySof® IQ Toric IOL
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:
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)
AcrySof® IQ Aspheric IOL
Not available in the United States. International Only.
The information and materials within these sections do not pertain to the US market. Not all products are approved in every market, and approved labeling and instructions may vary by local country.
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).
AcrySert® C Delivery System
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.
INFINITI® Vision System
Please refer to Product Labeling information for the INFINITI® Vision
System.
LenSx® Laser
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.
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. United States Federal Law restricts the use of this device to practitioners who have been trained in the operation of this device.
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, glaucoma, 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)
- This device is not intended for use in pediatric surgery
- A history of lens with zonular instability.
- Any contraindication to cataract or keratoplasty surgery.
Attention:
Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.
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