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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."
WaveLight® EX500 Excimer Laser
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.
AcrySof® Cachet® Phakic Angle Supported 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.
CAUTION: Federal law restricts this device to sale by or on the
order of a physician.
DESCRIPTION: The AcrySof® Phakic Angle Supported
Anterior Chamber Intraocular Lens (IOL) is intended for the reduction or elimination
of moderate to high myopia in adult patients 21 years of age or older having an
anterior chamber depth > 3.2 mm (measured including corneal thickness). The IOL
is surgically positioned in the angle (iris/cornea junction) of the anterior chamber
of the phakic eye in order to provide refractive correction. No supplemental fixation
or enclavation is required.
WARNINGS: Patients with significant preoperative astigmatism (determined
by keratometry) or expected postoperative astigmatism > 2.0 D may not achieve optimal
visual outcomes. The patient’s central and peripheral endothelial cell density (ECD)
should be monitored periodically (at least annually) since the long term effects
of this lens on the corneal endothelium have not been established. If elevated rates
of loss in ECD are observed, the patient should be informed and more frequent monitoring
is recommended. Elevated rates of cell loss over time or sudden, dramatic increases
in cell loss may require the IOL to be explanted.
PRECAUTIONS: Careful and detailed 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. The patient must be informed of these risks and benefits
as well as precautionary measures to be taken to ensure optimal outcomes (e.g.,
importance of having exams at least annually, avoidance of eye rubbing, etc.). The
safety and effectiveness of this lens have not been substantiated in patients with
pre-existing ocular conditions and/or intraoperative complications which may include,
but are not limited to, those having: stable manifest refractions of less than 1
year, cataract formation, significant irregular corneal aberration, retinal conditions,
Amblyopia, clinically severe corneal dystrophy, irregular anterior chamber anatomy,
anterior or posterior segment inflammation, Aniridia, iris neovascularization, glaucoma
or uncontrollable pressure, micro-/macrophthalmos, optic nerve atrophy, corneal
transplant, ocular condition(s) which may impact stability of the IOL, pregnancy,
vitreous loss. Clinical complications which have been encountered with this IOL
include raised IOP requiring treatment, cataract formation, surgical reintervention,
synechiae, raised IOP requiring hospitalization, BSCVA loss > 0.2 logMAR and corneal
haze. A high level of surgical skill is required for implantation and as such the
surgeon should have successfully completed an Alcon approved training program for
the AcrySof® Phakic Angle Supported IOL prior to beginning implantations
with this IOL. ProVisc® Ophthalmic Viscosurgical Device is the recommended
cohesive viscoeleastic for use with this IOL. Improper delivery and/or orientation
of the IOL during surgery may increase the risk of surgical reintervention, including
explantation. Do not resterilize; do not store over 45° C; use only sterile irrigating
solutions such as BSS® or BSS PLUS® Sterile Intraocular
Irrigating Solution.
ATTENTION: Reference the Physician Labeling/Directions for Use
for a complete listing of indications, warnings, and precautions.
AcrySof® IQ ReSTOR® IOL
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATIONS: The AcrySof® IQ ReSTOR® Apodized Diffractive
Optic 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.
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 Physician Labeling. Some adverse
reactions that have been associated with the implantation of intraocular lenses
are: hypopyon, intraocular infection, acute corneal decompensation, macular edema,
pupillary block, retinal detachment, and secondary surgical intervention (including
but not limited to lens repositioning, biometry error, visual disturbances, or patient
dissatisfaction). As a result of the multifocality, some visual effects (halos or
radial lines around point sources of light at night) may also be expected due to
the superposition of focused and unfocused multiple images. A reduction in contrast
sensitivity may also be experienced by some patients, especially in low lighting
conditions such as driving at night. In order to achieve optimal visual performance
with this lens, emmetropia must be targeted. Patients with significant preoperative
or expected postoperative astigmatism >1.0D may not achieve optimal visual outcomes.
Care should be taken to achieve IOL centration, as lens decentration may result
in a patient experiencing visual disturbances under certain lighting conditions.
PRECAUTIONS: Do not resterilize. Do not store over 45° C. Use only sterile irrigating
solutions such as BSS® or BSS PLUS® Sterile Intraocular
Irrigating Solution. Clinical studies with the AcrySof® ReSTOR®
IOL indicated that posterior capsule opacification (PCO), when present, developed
earlier into clinically significant PCO. 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 (eg, glaucoma, diabetic retinopathy,
chronic uveitis, and other retinal or optic nerve diseases) has not been studied.
The long-term effects of filtering blue light and the clinical efficacy of that
filtering on the retina have not been conclusively established.
ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing
of indications, warnings, and precautions.
AcrySof® IQ Toric IOL
Currently AcrySof® IQ Toric IOL is only available in the United States.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INDICATIONS: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, and SN6AT5
Posterior Chamber Intraocular lenses are intended for primary implantation in the
capsular bag of the eye for the visual correction of aphakia and pre-existing corneal
astigmatism secondary to the 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.
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.
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.
PRECAUTIONS: 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 (eg, 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.
AcrySof® IQ ReSTOR® Multifocal Toric 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.
CAUTION: Federal law restricts this device to the sale by or on the order of a physician.
INDICATIONS: The AcrySof® IQ ReSTOR® Multifocal Toric
IOL is intended for primary implantation for the visual correction of aphakia and
pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult
patients with and without presbyopia, who desire near, intermediate, and distance
vision, reduction of residual refractive cylinder, and increased spectacle independence.
The AcrySof® IQ ReSTOR® Multifocal Toric IOL is indicated
for the replacement of the human lens in refractive lens exchange (RLE) in adult
patients who may benefit from near vision without a reading aid, and from increased
spectacle independence. The lens is intended to be placed in the capsular bag.
WARNINGS: The safety and effectiveness of the AcrySof® IQ ReSTOR®
Multifocal Toric IOL have not been clinically studied. Careful preoperative evaluation
and sound clinical judgment should be used by the surgeon to decide the benefit/risk
ratio before implanting a lens in a patient with any of the conditions described
in the Directions for Use labeling. Some visual effects may be expected due to the
superposition of focused and unfocused multiple images. These may include some perceptions
of halos or radial lines around point sources of light under nighttime conditions.
A reduction in contrast sensitivity as compared to a monofocal IOL may be experienced
by some patients and may be more prevalent in low lighting conditions. Therefore,
multifocal patients should exercise caution when driving at night or in poor visibility
conditions. 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.
PRECAUTIONS: 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 (eg, 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.
INFINITI® Vision System
Please refer to Product Labeling information for the INFINITI® Vision System.