Bausch & Lomb PureVision2 for Astigmatism Contact Lenses User Manual

PACKAGE INSERT / FITTING GUIDE

Toric

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

Name and Address of Manufacturer: Bausch & Lomb Incorporated Rochester, New York, USA 14609 Printed in the U.S.A.

SL-7345

8129200

SYMBOL REFERENCE GUIDE

For labels and cartons:

Indicates the CE Conformity Marking and the

Notified Body Number

Fee Paid for Waste Management

Sterile Using Steam or Dry Heat

See Instruction Leaflet

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

Sphere Power (Diopters)

Cylinder Axis (Degrees)

Cylinder Power (Diopters)

Storage Temperature

TABLE OF CONTENTS

Important 2 Description 3 Lens Parameters Available 5 How the Lens Works (Actions) 5 Indications 6 Contraindications 7 Warnings 8 Precautions 10 Adverse Reactions 14 Clinical Study 15 Selection of Patients 20 Fitting Procedure 21

Pre-fitting Examination 21 Initial Lens Power Selection 21 Initial Lens Evaluation 21 Criteria of a Well-fitted Lens 22 Characteristics of a Tight (Steep) Lens 22 Characteristics of a Loose (Flat) Lens 23 Follow-up Care 23

Practitioner Fitting Sets 24 Wearing Schedule 24 Monovision Fitting Guidelines 25 Patient Selection 25

Eye Selection 25 Special Fitting Considerations 26 Near Add Determination 26 Trial Lens Fitting 27 Adaptation 27 Other Suggestions 28

Handling of Lens 29 Patient Lens Care Directions 29

Frequent Replacement and Disposable Wear 29 Care for a Sticking (Nonmoving) Lens 29 Emergencies 30 Reporting of Adverse Reactions 30 How Supplied 30

IMPORTANT

This package insert and fitting guide has been developed to provide practitioners with information covering characteristics of the Bausch + Lomb PureVision®2 Toric (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 Toric (balafilcon A) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available as a flexible shell with a toric surface. 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

[cm3O2(STP) x cm]/(sec x cm2 x mmHg) @ 35° C Polarographic Method (Boundary and Edge Corrected)

–11

101 x 10

[cm3O2(STP) x cm]/(sec x cm2 x mmHg) @ 35°C Polarographic Method (Boundary Corrected, Non-Edge Corrected)

The Bausch + Lomb PureVision 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 anterior surface of the lens contains the spherical power, prism ballast and comfort chamfer feature of the Bausch + Lomb PureVision®2 Toric (balafilcon A) Visibility Tinted Contact Lens. The posterior surface is manufactured with a spherocylindrical curve to accommodate the required astigmatic power.

Guide Mark System

Each Bausch + Lomb PureVision®2 Toric (balafilcon A) Visibility Tinted Contact Lens is marked with 1 Guide Mark, in the lens perimeter at 6 o’clock. This Guide Mark gives an instant reference for estimating lens rotation and orientation. It is in effect, a protractor guide on the lens surface. The guide mark make proper axis orientation and fitting faster and easier.

2 Toric (balafilcon A) Visibility Tinted Contact

Aspheric optical surfaces designed to reduce the population average spherical aberration across all sphere, cylinder, and axis combinations.

A hybrid ballasting geometry designed to optimize thickness from apex to base of lens and offer excellent orientation and alignment.

A smooth rounded profile

(6 o’clock)

Center Guide

designed to provide comfort plus optimal movement over the conjunctival tissue.

LENS PARAMETERS AVAILABLE

The Bausch + Lomb PureVision®2 Toric (balafilcon A) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:

Diameter: 14.5mm Center Thickness: 0.05mm to 0.50mm Base Curve: 8.9mm Sphere Powers: +6.00D to -9.00D in 0.25D steps (0.50D steps above –6.00D) Cylinder Powers: –0.75D, –1.25D, –1.75D, -2.25D and -2.75D Axis: 10° to 180° in 10° increments

*Additional powers may be introduced over time, check for product availability.

Lens Prism: Prism is located at the base of the lens to stabilize lens positioning when lens is on the eye. Comfort Chamfer: A wedge-shaped tapered section on the anterior surface of the lens in the periphery of the lens from the 3 to 9 o’clock areas. This reduces lens thickness.

HOW THE LENS WORKS (ACTIONS)

In its hydrated state, the Bausch + Lomb PureVision®2 Toric (balafilcon A) Visibility Tinted Contact Lens has a unique hybrid ballasting design that results in excellent stability and when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

INDICATIONS

Vision Correction

The Bausch + Lomb PureVision®2 Toric (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) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 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 -9.00D 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.

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 Toric (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 Toric (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 Toric (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 Toric (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.

• 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.

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.

• 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 (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 Toric (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 injur y to the eye.

2 Toric

• 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 Toric (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 Toric (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.

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