User Manual

Multi-Focal Fitting Guidelines 23
Patient Selection 23
Lens Selection 23
Lens Fitting 23
Symptom Resolution 23
Patient Education 24
Monovision Fitting Guidelines 24
Patient Selection 24
Eye Selection 25
Special Fitting Considerations 25
Near Add Determination 26
Trial Lens Fitting 26
Adaptation 27
Other Suggestions 27
Handling of Lens 28
Patient Lens Care Directions 28
Frequent Replacement and Disposable Wear 28
Care for a Sticking (Nonmoving) Lens 28
Care for a Dried Out (Dehydrated) Lens 29
Emergencies 29
Reporting of Adverse Reactions 30
How Supplied 30
© Bausch & Lomb Incorporated. All rights reserved worldwide.
®/TM are trademarks of Bausch & Lomb Incorporated.
Other product/brand names are trademarks of their respective owners.
Name and Address of Manufacturer:
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, New York, USA 14609
Printed in the U.S.A.
SYMBOL REFERENCE GUIDE
For labels and cartons:
Indicates the CE Conformity Marking and the Notified
Body Number
Member Green Dot Scheme
Sterile Using Steam or Dry Heat
Caution
Diameter
Use by Date (Expiration Date)
Batch Code
Authorized Representative in European Community
Caution: Federal law restricts this device to sale by or on
the order of a licensed practitioner
Diopter (Lens Power)
Base Curve
Low or High Add Power
Storage Temperature
TABLE OF CONTENTS
Important 3
Description 3
Lens Parameters Available 4
How the Lens Works (Actions) 4
Indications 4
Contraindications 5
Warnings 6
Precautions 8
Adverse Reactions 11
Clinical Study 13
Selection of Patients 18
Fitting Procedure 19
Pre-fitting Examination 19
Initial Lens Power Selection 19
Initial Lens Evaluation 20
Criteria of a Well-fitted Lens 20
Characteristics of a Tight (Steep) Lens 20
Characteristics of a Loose (Flat) Lens 21
Follow-up Care 21
Practitioner Fitting Sets 22
Wearing Schedule 22
IMPORTANT
This package insert and fitting guide has been developed to provide professionals with
information covering characteristics of the Bausch + Lomb PureVision
®
2 Multi-Focal
(balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It
is effective as of June 2013 and supersedes all prior fitting guides for the product
described. Please read carefully and keep this information for future use.
This package insert and fitting guide is intended for the eye care professional, but should
be made available to patients upon request. The eye care professional should provide
the patient with the patient instructions that pertain to the patient’s prescribed lens and
the recommended wearing schedule.
DESCRIPTION
The Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens is a soft hydrophilic contact lens that is a front surface asphere consisting of
multiple aspheric zones with a spherical base curve. The most plus power is in the center
of the lens, progressing to more minus in the periphery. The lens material, balafilcon A,
is a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker
and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in
a sterile borate buffered saline solution. This lens is tinted blue with up to 300 ppm of
Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: 1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. value—at least 95%
Water Content: 36%
Oxygen Permeability: 91 x 10
–11
[cm
3
O
2
(STP) x cm]/(sec x cm
2
x mmHg) @
35° C Polarographic Method
(Boundary and Edge Corrected)
101 x 10
–11
[cm
3
O
2
(STP) x cm]/(sec x cm
2
x mmHg)
@ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)
The Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens, with AerGel™ technology lens material, are manufactured by a cast molding
process and are treated by the Performa™ surface treatment process which transforms
hydrophobic silicone to hydrophilic silicate. The Bausch + Lomb PureVision2 Multi-
Focal (balafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/
Planned Replacement or Disposable Wear.
LENS PARAMETERS AVAILABLE
The Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens is a hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: Varies with power
(0.07mm at -3.00D)
Base Curve: 8.6mm
Powers (Spherical): +6.00D to -10.00D in (0.25D increments)
Add Powers: Low and High
*Additional powers may be introduced over time, check for product availability.
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A)
Visibility Tinted Contact Lens when placed on the cornea, acts as a refracting medium to
focus light rays on the retina.
INDICATIONS
The Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact
Lens is indicated for daily wear or extended wear from 1 to 30 days between removals,
for cleaning and disinfection or disposal of the lens, as recommended by the eye care
professional. The lens is indicated for the correction of refractive ametropia (myopia,
hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons
with non-diseased eyes, exhibiting astigmatism of up to 2.00 diopters, that does
not interfere with visual acuity. The lens may be prescribed for Frequent / Planned
Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to
-18.00D when prescribed for up to 30 days of extended wear and from +20.00D to
–20.00D for daily wear or extended wear up to 7 days with add powers ranging from
+0.75D to +5.00D.
Note: See the WARNINGS reference to the relationship between lens wearing
schedule and corneal complications.
FREQUENT / PLANNED REPLACEMENT WEAR
When prescribed for Frequent / Planned Replacement Wear, the Bausch + Lomb
PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is to be cleaned,
rinsed and disinfected each time it is removed from the patient’s eye and discarded after
the recommended wearing period prescribed by the eye care professional. The lens
may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb PureVision
®
2 Multi-Focal
(balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.
CONTRAINDICATIONS
(REASONS NOT TO USE)
DO NOT USE the Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility
Tinted Contact Lens when any of the following conditions exist:
• Acute and subacute inflammation or infection of the anterior chamber of
the eye
• Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by wearing contact
lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that
may be induced or exaggerated by wearing contact lenses or use of contact lens
solutions
• Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to be
used to care for the Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility
Tinted Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS
After a thorough eye examination, including appropriate medical background, patients
should be fully apprised by the prescribing professional of all the risks with contact lens
wear. Patients should be advised of the following warnings pertaining to contact
lens wear:
• Problems with contact lenses and lens care products could result in serious injury to
the eye. It is essential that patients follow their eye care professional’s direction and all
labeling instructions for proper use of lenses and lens care products, including the lens
case. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of
vision.
• When prescribed for Frequent / Planned Replacement Wear, the need for strict
compliance with the care regimen including cleaning of the lens case, wearing
restrictions, wearing schedule, and follow-up visit schedule should be emphasized to
the patient.
• Studies have shown that contact lens wearers who are smokers have a higher
incidence of adverse reactions than nonsmokers.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of
the eye, the patient should be instructed to immediately remove lenses and promptly
contact his or her eye care professional.
EXTENDED WEAR
• The risk of microbial keratitis has been shown to be greater among users of extended
wear contact lenses than among users of daily wear contact lenses. The risk among
extended wear lens users increases with the number of consecutive days that the
lenses are worn between removals, beginning with the first overnight use.
• Some researchers believe that these complications are caused by one or more of the
following: a weakening of the cornea’s resistance to infections, particularly during a
closed-eye condition, as a result of hypoxia; an eye environment which is somewhat
more conducive to the growth of bacteria and other microorganisms, particularly
when a regular periodic lens removal and disinfecting or disposal schedule has not
been adhered to by the patient; improper lens disinfection or cleaning by the patient;
contamination of lens care products; poor personal hygiene by the patient; patient
unsuitability to the particular lens or wearing schedule; accumulation of lens deposits;
damage to the lens; improper fitting; length of wearing time; and the presence of ocular
debris or environmental contaminants.
• While the great majority of patients successfully wear contact lenses, extended wear of
lenses also is reported to be associated with a higher incidence and degree of epithelial
microcysts and infiltrates, and endothelial polymegathism, which require consideration
of discontinuation or restriction of extended wear. The epithelial conditions are
reversible upon discontinuation of extended wear.
• The risk of microbial keratitis has not been determined for this lens. Post marketing
studies are in progress.
• The reversibility of endothelial effects of contact lens wear has not been conclusively
established. As a result, professionals’ views of extended wearing times vary from not
prescribing extended wear at all to prescribing flexible wearing times from occasional
overnight wear to prescribing extended wearing periods from 1 to 30 days with
specified intervals of no lens wear for certain patients, with follow-up visits, and with
proper care regimen.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or redness of
the eye, the patient should be instructed to immediately remove lenses and promptly
contact his or her eye care professional.
PRECAUTIONS
Precautions for Eye Care Professionals
• Due to the small number of patients enrolled in clinical investigation of lenses, all
refractive powers, design configurations, or lens parameters available in the lens
material are not evaluated in significant numbers. Consequently, when selecting an
appropriate lens design and parameters, the eye care professional should consider all
characteristics of the lens that can affect lens performance and ocular health, including
oxygen permeability, wettability, central and peripheral thickness, and optic zone
diameter.
• The oxygen transmissibility is below the established threshold required to prevent
overnight corneal edema for portions of the power range, including plus powers and
some low minus power lenses.
1
In the U.S. clinical study of the PureVision (spherical)
lens, the rate of infiltrative keratitis was found to be higher with higher lens powers (see
Clinical Study section of the package insert).
• The potential impact of these factors on the patient’s ocular health should be carefully
weighed against the patient’s need for refractive correction; therefore, the prescribing
eye care professional should carefully monitor the continuing ocular health of the
patient and lens performance on eye.
• Patients who wear aspheric contact lenses, such as the Bausch + Lomb PureVision2
Multi-Focal (balafilcon A) Visibility Tinted Contact Lens, to correct presbyopia may not
achieve the best corrected visual acuity for either far or near vision. Visual requirements
vary with the individual and should be considered when selecting the most appropriate
type of lens for each patient.
• Eye care professionals should instruct the patient to REMOVE A LENS
IMMEDIATELY if an eye becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The
lenses absorb this dye and become discolored. Whenever fluorescein is used in eyes,
the eyes should be flushed with sterile saline solution that is recommended for in-eye
use.
• The patient should be instructed to always discard disposable lenses and lenses worn
on a Frequent / Planned Replacement schedule after the recommended wearing
schedule prescribed by the eye care professional.
• Some patients will not be able to tolerate continuous wear even if able to tolerate the
same or another lens on a daily wear basis. Some patients who are able to tolerate
continuous wear will not be able to wear their lenses continuously for 30 days. Patients
should be carefully evaluated for continuous wear prior to prescription and dispensing,
and eye care professionals should conduct early and frequent follow-up examination to
determine ocular response to continuous wear.
• As with any contact lens, follow-up visits are necessary to assure the continuing health
of the patient’s eyes. The patient should be instructed as to a recommended follow-up
schedule.
• Aphakic patients should not be fitted with Bausch + Lomb PureVision
®
2 Multi-Focal
(balafilcon A) Visibility Tinted Contact Lenses until the determination is made that the
eye has healed completely.
Eye care professionals should carefully instruct patients about the following lens
care and safety precautions. It is strongly recommended that patients be provided
with a copy of the Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility
Tinted Contact Lens Patient Information Booklet available from Bausch + Lomb and
understand its contents prior to dispensing the lenses.
Handling Precautions
• Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions,
soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on
lenses before putting on makeup. Water-base cosmetics are less likely to damage
lenses than oil-base products.
• Be sure that before leaving the eye care professional’s office, the patient is able to
remove lenses promptly or have someone else available to remove them.
• Be certain that the fingers or hands are free of foreign materials before touching lenses,
as microscopic scratches of the lenses may occur, causing distorted vision and/or injury
to the eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and
wearing instructions in the Patient Information Booklet for the Bausch + Lomb
PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and those
prescribed by the eye care professional.
• Never use tweezers or other tools to remove lenses from the lens container unless
specifically indicated for that use. Pour the lens into the hand.
Solution Precautions
Do not use the Allergan Ultracare Disinfecting System or any of its components
(Ultracare Disinfecting Solution, Ultracare Neutralizing Tablets, Lens Plus
Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to clean and disinfect
the Bausch + Lomb PureVision
®
2 Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens because the lens dimensions will be altered.
Eye injury due to irritation or infection may result from lens contamination. To reduce
the risk of contamination, review the appropriate manufacturer’s labeled lens care
instructions with the patient.
• Always use fresh unexpired lens care solutions.
• Always follow directions in the package inserts for the use of contact lens solutions.
• Sterile unpreserved solutions, when used, should be discarded after the time specified
in the labeling directions.
• Always keep the lenses completely immersed in the recommended storage solution
when lenses are not being worn (stored). Prolonged periods of drying will damage
lenses. Follow the lens care directions for Care for a Dried Out (Dehydrated) Lens in
the Patient Information Booklet if lens surface does become dried out.
• Do not use saliva or anything other than the recommended solution for lubricating or
wetting lenses.
• Tap water, distilled water or homemade saline should not be used as a substitute for
any component in the lens care regimen since they have been associated with an
Acanthamoeba keratitis infection.
• Never use conventional hard contact lens solutions that are not also recommended for
use with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in the lens care
system labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions
• Never wear lenses beyond the period recommended by the eye care professional.
• If the lens sticks (stops moving) on the eye, follow the recommended directions on
Care for a Sticking Lens. The lens should move freely on the eye for the continued
health of the eye. If nonmovement of the lens continues, the patient should be instructed
to immediately consult his or her eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while wearing lenses.
• If aerosol products are used while wearing lenses, exercise caution and keep eyes
closed until the spray has settled.
Lens Case Precautions
• Contact lens cases can be a source of bacterial growth. To prevent contamination and
to help avoid serious eye injury, always empty and rinse the lens case with fresh, sterile
rinsing solution and allow to air dry.
• Lens cases should be replaced monthly or as frequently as recommended by the lens
case manufacturer or eye care professional.
Topics to Discuss with the Patient
• As with any contact lens, follow-up visits are necessary to assure the continuing health
of the eyes. The patient should be instructed as to a recommended follow-up schedule.
• Patients should be advised about wearing lenses during sporting and water related
activities. Exposure to water while wearing contact lenses in activities such as
swimming, water skiing and hot tubs may increase the risk of ocular infection including
but not limited to Acanthamoeba keratitis.
• Always contact the eye care professional before using any medicine in the eyes.
Who Should Know That the Patient is Wearing Contact Lenses
• Patients should inform their doctor (health care professional) about being a contact
lens wearer.
• Patients should always inform their employer of being a contact lens wearer. Some jobs
may require the use of eye protection equipment or may require that you do not wear
lenses.
ADVERSE REACTIONS
The patient should be informed that the following problems may occur:
• Eyes stinging, burning, itching (irritation), or other eye pain
• Comfort is less than when lens was first placed on eye
• Abnormal feeling of something in the eye (foreign body, scratched area)
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• Sensitivity to light (photophobia)
• Dry eyes
If the patient notices any of the above, he or she should be instructed to
• Immediately remove the lenses.
• If the discomfort or problem stops, the patient should look closely at the lens. If the
lens is in any way damaged, do not put the lens back on the eye. The patient should
place the lens in the storage case and contact the eye care professional. If the lens
has dirt, an eyelash, or other foreign body on it, or the problem stops and the lens
appears undamaged, the patient should thoroughly clean, rinse, and disinfect the
lenses; then reinsert them. After reinsertion, if the problem continues, the patient should
immediately remove the lenses and consult his or her eye care professional.
If the above symptoms continue after removal of the lens, or upon reinsertion of a lens,
or upon insertion of a new lens, the patient should immediately remove the lenses
and contact his or her eye care professional or physician, who must determine
the need for examination, treatment or referral without delay. (See Important Treatment
Information for Adverse Reactions.) A serious condition such as infection, corneal
ulcer, corneal vascularization, or iritis may be present, and may progress rapidly. Less
serious reactions such as abrasions, epithelial staining or bacterial conjunctivitis must be
managed and treated carefully to avoid more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can develop
rapidly, and therefore early recognition and treatment of problems are critical. Infectious
corneal ulceration is one of the most serious potential complications, and may be
ambiguous in its early stage. Signs and symptoms of infectious corneal ulceration
include discomfort, pain, inflammation, purulent discharge, sensitivity to light, cells and
flare, and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes
similar. Accordingly, such epithelial defect, if not treated properly, may develop into an
infected ulcer. In order to prevent serious progression of these conditions, a patient
presenting symptoms of abrasions or early ulcers should be evaluated as a potential
medical emergency, treated accordingly, and be referred to a corneal specialist when
appropriate. Standard therapy for corneal abrasions such as eye patching or the use of
steroids or steroid/antibiotic combinations may exacerbate the condition. If the patient is
wearing a contact lens on the affected eye when examined, the lens should be removed
immediately and the lens and lens care products retained for analysis and culturing.
CLINICAL STUDY
The following clinical results are provided for informational purposes. It is important
to note that the results below are from a study conducted with the Bausch + Lomb
PureVision
®
(balafilcon A) Visibility Tinted Contact Lens which has the same lens
material, but different lens design. The study was conducted with subjects not requiring
presbyopic correction.
STUDY DESCRIPTION
Study Design
The objective of this 12-month study was to evaluate the safety and efficacy of the
PureVision (balafilcon A) Visibility Tinted Contact Lenses worn on a 30-day continuous
wear basis, compared to a conventional Control lens worn on a 7-day continuous wear
basis. A total of 1640 eyes (820 subjects) were enrolled into this study. Subjects were
fitted with a PureVision Contact Lens on one eye while the contralateral eye was fitted
with a Control lens. Subjects were instructed to replace the PureVision Contact Lens
with a new lens every 30 days, and to wear the Control lens overnight for up to six
consecutive nights per week. Eyes had one night without lens wear after the scheduled
removal. The Control lens was to be replaced with a new lens every 14 days.
Six hundred ten (610) subjects completed the one-year study. Ten subjects discontinued
in the daily wear adaptation period, 182 subjects discontinued during the extended
wear phase and 18 subjects were not dispensed lenses.
Patient Assessments
Subjects were evaluated at follow-up visits scheduled after 24 hours, 10 days, 1 month,
3 months, 6 months, 9 months, and 12 months of lens wear.
Demographics
Subject recruitment was open to adapted and unadapted contact lens wearers. There
were no restrictions as to the subject’s gender or occupation, but subjects were required
to be of legal age (typically 18 or 21) and have the legal capacity to volunteer. The
ages of the subjects ranged from 18 to 74 years of age, with a mean age of 33.6, and
included 574 females and 228 males, with a ratio of 2.52 females to every male. For
the PureVision Contact Lens the power range used was –0.50D to –9.00D. For the
Control lens the power range was –0.50D to –8.50D.
The previous lens wearing experience of the subjects that participated in the study was
5% no lens wear, 43% daily wear, and 51% continuous wear. The refractive errors of the
subjects ranged from –0.25D to –11.75D, and included up to –2.00D of astigmatism.
SUMMARY OF DATA ANALYSES
Summary of Data Analyses
The key endpoints for this study were:
1. Grade 2 and higher slit lamp findings (safety endpoint),
2. Grade 2 and higher corneal infiltrates (safety endpoint), and
3. Contact lens corrected visual acuity worse than 20/40 (efficacy endpoint).
For each key endpoint, the rates (incidents of endpoint/number of eyes) experienced
by eyes in the PureVision Contact Lens and Control lenses were calculated. The
difference in rates between the two lens types was determined and a 95% confidence
interval for the difference was calculated. For each key endpoint a “clinically significant
difference” in the rates was established before the study started. These “clinically
significant differences” were as follows: 10% for total slit lamp findings ≥Grade 2, 5%
for corneal infiltrates ≥ Grade 2, and 5% for the acuity endpoint. For example, if the
true rates of endpoint infiltrates in the subject population were 9.99% in the PureVision
Contact Lens and 5% in the Control lens, these rates would be considered substantially
equivalent (difference <5%).
In order to be successful for a given endpoint, the upper 95% confidence limit for the
difference in the study rates had to be less than the pre-established “clinically significant
difference.” This means that we are 95% confident that the true difference is within
tolerance. The safety and efficacy goals were met for all three key endpoints. Results
are as follows:
PureVision Control
Relative
Risk/
PureVision
Control
Difference
in %
Upper
95%
Confidence
Level
Clinically
Significant
Difference
Endpoint n % n %
Slit Lamp
Findings ≥
Grade 2
138 17.5% 139 1 7.6 % 1.0 -0.1% 2.6% 10.0%
Corneal
Infiltrates ≥
Grade 2
23 2.9% 10 1.3% 2.3 1.6% 2.9% 5.0%
Visual
Acuity Worse
than 20/40
0 0.0% 2 0.3% 0.0 -0.3% 0.1% 5.0%
PACKAGE INSERT / FITTING GUIDE
SL-7343
8128800
2
6
10
14
5
9
13
4
8
12
3
7
11
1
Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for Daily and Extended Wear
Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.
CAUTION: Federal law restricts this device to
sale by or on the order of a licensed practitioner.
For Presbyopia
Multi-Focal