Bausch-lomb PureVision2 for Astigmatism Contact Lenses User Manual download pdf

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.

®/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

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

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

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

[cm

(STP) x cm]/(sec x cm

x mmHg)

@ 35° C Polarographic Method

(Boundary and Edge Corrected)

101 x 10

–11

[cm

(STP) x cm]/(sec x cm

mmHg) @ 35°C Polarographic Method

(Boundary Corrected, Non-Edge Corrected)

The Bausch + Lomb PureVision

2 Toric (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 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.

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

designed to provide comfort

plus optimal movement over

the conjunctival tissue.

(6 o’clock)

Center Guide

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.

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.

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.

• 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 Toric

(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 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 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.

PACKAGE INSERT / FITTING GUIDE

SL-7345

8129200

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.

Toric

1 2 3 4

Summary of Contents

Page 1

IMPORTANTThis package insert and fitting guide has been developed to provide practitioners with information covering characteristics of the Bausch + L

Page 2

IMPORTANTThis package insert and fitting guide has been developed to provide practitioners with information covering characteristics of the Bausch + L

Page 3

Important Treatment Information for Adverse ReactionsSight-threatening ocular complications associated with contact lens wear can develop rapidly, and

Page 4

Important Treatment Information for Adverse ReactionsSight-threatening ocular complications associated with contact lens wear can develop rapidly, and

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Bausch-lomb PureVision2 for Astigmatism Contact Lenses User Manual

Browse online or download User Manual for Health and hygiene Bausch-lomb PureVision2 for Astigmatism Contact Lenses. Bausch &amp; Lomb PureVision2 for Astigmatism Contact Lenses User Manual [fr]

Summary of Contents

Comments to this Manuals

Related products and manuals for Health and hygiene Bausch-lomb PureVision2 for Astigmatism Contact Lenses

Browse online or download User Manual for Health and hygiene Bausch-lomb PureVision2 for Astigmatism Contact Lenses. Bausch & Lomb PureVision2 for Astigmatism Contact Lenses User Manual [fr]