Bausch & Lomb PureVision Multi-Focal Contact Lenses User Manual

Multi-Focal

Multi-Focal

Visibility Tinted
Contact Lenses

PACKAGE INSERT/
FITTING GUIDE

CAUTION: Federal (U.S.A.) law restricts this
device to sale by or on the order of a licensed
practitioner.

IMPORTANT:
This package insert and fitting guide has been developed to provide practition­ers with information covering characteristics of the BAUSCH & LOMB®
PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens and to illus­trate fitting procedures. It is effective as of October 2005 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® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a soft hydrophilic contact lensthat 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%

-11

Oxygen Permeability: 91 x 10

The PureVision Multi-Focal Contact Lenses, with the AerGel™ lens material, are
manufactured by a cast molding process and are surface treated by the
Performa™ surface treatment process which transforms hydrophobic silicone to
hydrophilic silicate.

[cm3O2(STP) x cm]/(sec x cm2x
mmHg) @ 35° C Polarographic Method
(Boundary and Edge Corrected)

-11

[cm3O2(STP) x cm]/(sec x cm2x

101 x 10
mmHg) @ 35°C Polarographic Method
(Boundary Corrected, Non-Edge Corrected)

123

LENS PARAMETERS AVAILABLE:
The BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted
Contact Lens is a hemispherical shell of the following dimensions:
Diameter: 14.0mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.6mm
Sphere Powers: +6.00D to -10.00D (0.25D increments)
ADD Powers: Low (+0.75D to +1.50D) and High (+1.75D to +2.50D)

HOW THE LENS WORKS (ACTIONS):
In its hydrated state, the BAUSCH & LOMB® PureVision® 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® 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 or less, 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.

te: See the WARNINGS reference to the relationship between lens wearing

No
schedule and corneal complications.

FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision
Multi-Focal 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 PureVision Multi-Focal Contact Lens
is to be discarded after each removal.

CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB® PureVision® 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 PureVision Mulit-Focal 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 eye care 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.

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 microcycsts 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 long term 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
some plus powers and some low minus power lenses.
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 continuing ocular health of the patient and lens performance
on eye should be carefully monitored by the prescribing eye care profes­sional.

• Patients who wear aspheric contact lenses, such as the Bausch & Lomb
PureVision Multi-Focal, 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.

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.

1

In the U.S. clinical

456

• 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 PureVision 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 PureVision Multi-Focal 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. Water­base 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 PureVision Contact Lenses 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 PureVision Multi-Focal Contact Lens because the lens dimensions will be
altered.

• 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 at regular intervals as recommended by
the lens case manufacturer or eye care professional.