Bausch-lomb Optima Toric Contact Lenses User Manual download pdf

VISION CORRECTION USE

BAUSCH & LOMB

Optima

Toric (heﬁlcon B) Contact

Lenses.

For: Nearsightedness (Myopia), Farsightedness (Hyperopia),

Astigmatism, Not-aphakic

DESCRIPTION

The BAUSCH & LOMB

Optima

Toric (heﬁlcon B) Contact

Lens is a ﬂexible shell with toric surfaces. The lens material,

(heﬁlcon B), is a hydrophilic random copolymer of 2-

hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is

45% water by weight when immersed in a sterile saline

solution. The BAUSCH & LOMB

Optima

Toric (heﬁlcon B)

Contact Lens is a hemispherical shell of the following

dimensions:

• Diameter: 13.0mm to 15.0mm

• Center Thickness: 0.1mm to 1.0mm

• Base Curve: 8.3mm to 9.2mm

• Powers (Spherical): +6.00D to -9.00D

(Cylinder): up to 5.00D

The physical/optical properties of the lens are:

Speciﬁc Gravity: 1.1

Refractive Index: 1.42

Light Transmittance C.I.E. Y value - approximately

97%

Water Content: 45%

Oxygen Permeability(Dk): 13x 10

–11

[cm

(STP) x cm]

/ (sec x cm

x mmHg)@35˚ C

(Polarographic Method)

ACTIONS

In its hydrated state, the BAUSCH & LOMB

Optima

Toric

(heﬁlcon B) Contact Lens when placed on the cornea acts

as a refracting medium to focus light rays on the retina.

INDICATIONS

Daily Wear

The BAUSCH & LOMB

Optima

Toric (heﬁlcon B) Contact

Lens is indicated for vision correction of refractive

ametropia (myopia and hyperopia) in not-aphakic persons

with non-diseased eyes, that exhibit refractive astigmatism

up to 5.00 diopters. The lens may be prescribed in spherical

powers ranging from +6.00D to -9.00D.

The lens may be disinfected using either a heat or chemical

disinfection system. Eye Care Practitioners may prescribe

the lens for traditional or frequent/planned replacement

wearing schedule, with cleaning, disinfection and scheduled

replacement of the lens.

CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE the BAUSCH & LOMB

Optima

Toric

(heﬁlcon B) Contact Lens when any of the following condi-

tions 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

(surround-

ing 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

Optima

Toric (heﬁlcon B) 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 practitioner 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 practitioner’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.

• Daily wear lenses are not indicated for overnight wear, and

patients should be instructed not to wear lenses while

sleeping. Clinical studies have shown that the risk of

serious adverse reactions is increased when these lenses

are worn overnight.

• 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 practitioner.

PRECAUTIONS

Special Precautions for Eye Care Practitioners:

• Due to the small number of patients enrolled in clinical

investigation of lenses, all refractive powers, design con-

ﬁgurations, or lens parameters available in the lens mater-

ial are not evaluated in signiﬁcant numbers. Consequently,

when selecting an appropriate lens design and parameters,

the eye care practitioner 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 potential impact of these factors on the patient’

ocular health should be carefully weighed against the

patient’s need for refractive correction; therefore, the con-

tinuing ocular health of the patient and lens performance

on eye should be carefully monitored by the prescribing

eye care practitioner.

• Fluorescein should not be used while the patient is

wearing the lenses, because the lenses will become discol-

ored. Whenever ﬂuorescein is used, ﬂush the eyes with

sterile saline solution. Wait at least 5 minutes before rein-

serting the lenses. If it is not possible to ﬂush the eyes,

wait a minimum of 1 hour before reinserting the lenses.

If replaced too soon, the lenses may absorb residual

ﬂuorescein.

• Before leaving the eye care practitioner’s ofﬁce, the patient

should be able to promptly remove lenses or should have

someone else available who can remove the lenses for him

or her.

Eye care practitioners should carefully instruct patients

about the following care regimen and safety precautions:

• Different solutions cannot always be used together, and

not all solutions are safe for use with all lenses. Use only

recommended solutions.

• - Never use solutions recommended for conventional hard

contact lenses only.

• - Chemical disinfection solutions should not be used with

heat unless speciﬁcally indicated on product labeling for

use in both heat and chemical disinfection.

• - 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 dis-

carded after the time speciﬁed in the labeling directions.

• - Do not use saliva or anything other than the recom-

mended solutions for lubricating or wetting lenses.

• - Always keep the lenses completely immersed in the rec-

ommended storage solution when the lenses are not

being worn. Prolonged periods of drying can damage

lenses. Follow the lens care directions for Care for a

Dried Out (Dehydrated) Lens if lens surface does become

dried out.

• If the lens sticks (stops moving) on the eye, follow the rec-

ommended 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 practitioner.

• 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.

• Do not touch contact lenses with the ﬁngers or hands if

the hands are not free of foreign materials, as microscopic

scratches of the lenses may occur, causing distorted vision

and/or injury to the eye.

• Carefully follow the handling, insertion, removal, cleaning,

disinfecting, storing and wearing instructions

in the Patient Information Booklet for the BAUSCH &

LOMB

Optima™ Toric (heﬁlcon B) Contact Lens and

those prescribed by the eye care practitioner.

• Never wear lenses beyond the period recommended by the

eye care practitioner.

• If aerosol products such as hair spray are used while

wearing lenses, exercise caution and keep eyes closed

until the spray has settled.

• Always handle lenses gently and avoid dropping them.

• Avoid all harmful or irritating vapors and fumes while

wearing lenses.

• Ask the eye care practitioner about wearing lenses during

water activities and other sports.

• Inform the doctor (health care practitioner) about being a

contact lens wearer.

• 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.

• Do not touch the lens with ﬁngernails.

• Always discard lenses and lenses worn on a

frequent/planned replacement wearing schedule after the

recommended wearing schedule prescribed by the eye

care practitioner.

• Always contact the eye care practitioner before using any

medicine in the eyes.

•

Always inform the employer of being a contact lens

wearer.

Some jobs may require use of eye protection

equipment or may require that the patient not wear

contact lenses.

• 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.

ADVERSE REACTIONS

The patient should be informed that the following problems

may occur:

• Eye 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 lenses.

• If the discomfort or problem stops, then look closely at the

lens. If the lens is in any way damaged, do not put the lens

back on the eye. Place the lens in the storage case and

contact the eye care practitioner. 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 thor-

oughly clean, rinse, and disinfect the lenses; then reinsert

them. After reinsertion, if the problem continues, the

patient should immediately remove the lenses and

consult the eye care practitioner.

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 lens and

contact his or her eye care practitioner 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 infec-

tion, corneal ulcer, corneal vascularization, or iritis may be

present, and may progress rapidly. Less serious reactions

such as abrasions, epithelial stinging or bacterial conjunc-

tivitis 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 com-

plications, and may be amibiguous in its early stage. Signs

and symptoms of infectious corneal ulceration include dis-

comfort, 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 con-

ditions, a patient presenting symptoms of abrasions or early

ulcers should be evaluated as a potential medical

emer-

gency, treated accordingly, and be referred to a corneal spe-

cialist when appropriate. Standard therapy for corneal abra-

sions such as eye patching or the use of steroids or

steroid/antibiotic combinations may exacerbate the condi-

tion. If the patient is wearing a contact lens on the affected

eye when examined, the lens should be removed immedi-

ately and the lens and lens care products retained for analy-

sis and culturing.

FITTING

Conventional methods of ﬁtting contact lenses apply to

BAUSCH & LOMB

Optima™ Toric (heﬁlcon B) Contact

Lenses. It is very important for the eye care practitioner to

give the patient the Patient Information Booklet for Optima™

Toric (heﬁlcon B) Contact Lenses and review it with the

patient. For a detailed description of the ﬁtting techniques,

refer to the BAUSCH & LOMB

Optima™ Toric (heﬁlcon B)

Contact Lens Professional Fitting and Information Guide,

copies of which are available from:

Bausch & Lomb Incorporated

Rochester, New York 14603

Toll Free Telephone Number

In the Continental U.S., Alaska, Hawaii

1-800-828-9030

In New York State

1-800-462-1720

WEARING SCHEDULE

It is recommended that contact lens wearers see their eye

care practitioner twice each year or if directed, more fre-

quently.

Daily Wear:

There may be a tendency for the daily wear patient to over

wear the lenses initially. Therefore, the importance of adher-

ing to a proper, initial daily wearing schedule should be

stressed to these patients.

The wearing schedule should be dertermined by the eye

care practitioner. The wearing schedule chosen by the eye

care practitioner should be provided to the patient.

LENS CARE DIRECTIONS

Eye care practitioners should review with the patient lens

care directions, including both basic lens care information

and speciﬁc instructions on the lens care regimen recom-

mended for the patient:

General Lens Care (To First Clean and Rinse, Then

Disinfect Lenses)

Basic Instructions:

• Always wash, rinse, and dry hands before handling contact

lenses.

• Always use fresh unexpired lens care solutions.

• Use the recommended system of lens care, either heat

(thermal) or chemical (not heat) and carefully follow

instructions on solution labeling. Different solutions

cannot always be used together, and not all solutions

are safe for use with all lenses. Do not alternate

mix lens care systems unless indicated on solution

labeling.

• Do not use saliva or anything other than the recommended

solutions for lubricating or rewetting lenses. Do not put

lenses in the mouth.

• Lenses should be cleaned, rinsed, and disinfected each

time they are removed. Cleaning and rinsing are neces-

sary to remove mucus and ﬁlm from the lens surface.

Disinfecting is necessary to destroy harmful germs.

• Always remove, clean, rinse, enzyme and disinfect lenses

according to the schedule prescribed by the eye care prac-

titioner. The use of an enzyme or any cleaning solution

does not substitute for disinfection.

LENS CARE PRODUCT CHART

The following solutions are recommended by Bausch &

Lomb for use with BAUSCH & LOMB

Optima™ Toric

(heﬁlcon B) Contact Lenses; however, eye care practitioners

may recommend alternative products and procedures for

their patients. All components necessary for lens disinfec-

tion, cleaning and storage are available in BAUSCH &

LOMB

Care Kits.

Thermal Lens Care System

Action Care Product

Cleaning BAUSCH & LOMB

SENSITIVE

EYES

Daily Cleaner

Rinsing, Disinfecting

& Storing Commercially available Heat

Disinfection Unit for Contact Lenses

used with:

BAUSCH & LOMB

ReNu

Saline

Solution

BAUSCH & LOMB

SENSITIVE

EYES

Sterile Saline Spray

BAUSCH & LOMB

SENSITIVE

EYES

Saline Solution

BAUSCH & LOMB

SENSITIVE

EYES

Plus Saline Solution

Enzymatic Protein BAUSCH & LOMB

ReNu

Thermal

Removal Enzymatic Contact Lens Cleaner

BAUSCH & LOMB

ReNu

Effervescent Enzymatic Contact

Lens Cleaner

BAUSCH & LOMB

SENSITIVE EYES

Enzymatic Contact Lens Cleaner

• Note: Some solutions may have more than one function,

which will be indicated on the label. Read the label on the

solution bottle, and follow instructions.

• Clean one lens ﬁrst (always the same lens ﬁrst to avoid

mixups), rinse the lens thoroughly with recommended

saline or disinfecting solution to remove the cleaning solu-

tion, mucus, and ﬁlm from the lens surface, and put that

lens into the correct chamber of the lens storage case.

Then repeat the procedure for the second lens.

• After cleaning and rinsing, disinfect lenses using the

system recommended by the manufacturer and/or the eye

care practitioner.

• To store lenses, disinfect and leave them in the

closed/unopened case until ready to wear. If

lenses are not

to be used immediately after disinfection, you should

consult the labeling of the storage solution for information

on lens storage.

• After removing the lenses from the lens case, empty and

rinse the lens storage case with solution as recommended

by the lens case manufacturer; then allow the lens case to

air dry. When the case is used again, reﬁll it with storage

solution. Replace lens case at regular intervals.

• Eye care practitioners may recommend a lubricating/

rewetting solution which can be used to wet (lubricate)

lenses while they are being worn to make them more

comfortable.

• Lenses prescribed in a frequent replacement program

should be thrown away after the recommended wearing

period prescribed by the practitioner.

Heat (Thermal) Lens Disinfection:

• After cleaning and thoroughly rinsing contact lenses with

recommended solutions, prepare the empty lens storage

case. To keep the lenses wet during disinfection, use the

solution that is recommended by the lens manufacturer

and/or the eye care practitioner.

• Wet the lens chambers (sections) with fresh saline solution.

• Put each lens into its correct chamber.

• Fill the chamber of the case to the line with fresh saline

solution. Completely cover the lenses.

• Tightly close the top on each chamber of the lens storage case.

• Put the lens storage case into the disinfection unit and

follow the disinfection unit manufacturer’s directions for

operating the unit (turning the unit on, assuring that it

works, and leaving it on for a sufﬁcient time to disinfect

the lenses).

• Before reinsertion of the lenses, no rinsing is necessary

unless the eye care practitioner recommends rinsing.

Emergency (Alternate) Method for Heat (Thermal)

Disinfection:

• If a heat disinfection unit is not available, place the tightly

closed storage container which contains the lenses into a

pan of already boiling water. Leave the closed lens case in

the pan of boiling water for at least 10 minutes. (Above an

altitude of 7,000 feet, boil for at least 15 minutes.) Be

careful not to allow the water in the pan to boil away.

Remove the pan from the heat and allow it to cool for

30 minutes to complete the disinfection of the lens.

Note: Use of heat disinfection unit should be resumed as

soon as possible.

• Leave the lenses in the unopened storage case until

ready

to put on the eyes.

• Before reinsertion of the lenses, no rinsing is necessary

unless the eye care practitioner recommends rinsing.

Chemical (Not Heat) Disinfection:

• Clean the contact lenses with a recommended cleaning

solution and thoroughly rinse them with a recommended

rinsing solution.

• After cleaning and rinsing, to disinfect, carefully follow

the instructions accompanying the disinfecting solution in

the care regimen recommended by the lens manufacturer

or the eye care practitioner.

• When using hydrogen peroxide lens care systems, lenses

must be neutralized before wearing. Follow the recom-

mendations on the hydrogen peroxide system labeling.

• Thoroughly rinse lenses with a fresh solution recom-

mended for rinsing before inserting and wearing, or follow

the instructions on the disinfection solution labeling.

• Do not heat the disinfection solution and lenses.

• Leave the lenses in the unopened storage case until ready

to put on the eyes.

• Caution: Lenses that are chemically disinfected may

absorb ingredients from the disinfecting solution which

may be irritating to the eyes. A thorough rinse in fresh

sterile saline solution prior to placement on the eye should

reduce the potential for irritation.

LENS DEPOSITS AND USE OF ENZYMATIC

CLEANING PROCEDURE

Enzyme cleaning may be recommended by the eye care

practitioner. Enzyme cleaning removes protein deposits on

the lens. These deposits cannot be removed with regular

cleaners. Removing protein deposits is important for the

well-being of the patient’s lenses and eyes. If these deposits

are not removed, they can damage the lenses and cause

irritation.

Chemical Lens Care System

Action Care Product

Cleaning BAUSCH & LOMB

ReNu

Multi-

Purpose Solution

BAUSCH & LOMB

SENSITIVE EYES

Daily Cleaner

Disinfecting & BAUSCH & LOMB

ReNu

Multi-

Storing Purpose Solution

Rinsing BAUSCH & LOMB

ReNu

Multi-

Purpose Solution

BAUSCH & LOMB

SENSITIVE EYES

Saline Solution

BAUSCH & LOMB

ReNu

Saline

Solution

BAUSCH & LOMB

SENSITIVE EYES

Sterile Saline Spray

BAUSCH & LOMB

SENSITIVE EYES

Plus Saline Solution

Enzymatic Protein BAUSCH & LOMB

ReNu

Removal Effervescent Enzymatic Contact

Lens Cleaner

BAUSCH & LOMB

SENSITIVE EYES

Enzymatic Contact Lens Cleaner

BAUSCH & LOMB

ReNu

1 Step

Enzymatic Contact Lens Cleaner

All Lens Care Systems

Action Care Product

Rewetting BAUSCH & LOMB

ReNu

Rewetting Drops

BAUSCH &

LOMB

SENSITIVE EYES

Drops

Enzyme cleaning does NOT replace routine cleaning and dis-

infecting. For enzyme cleaning, the patient should carefully

follow the instructions in the enzymatic cleaning labeling.

LENS CASE CLEANING AND MAINTENANCE

Contact lens cases can be a source of bacteria growth. Lens

cases should be emptied, cleaned, rinsed with solutions rec-

ommended by the lens case manufacturer, and allowed to

air dry. Lens cases should be replaced at regular intervals.

CARE FOR A DRIED OUT (DEHYDRATED) OR

DRY LENS

If a soft, hydrophilic contact lens is exposed to air while off

the eye, it may become dry and brittle and need to be rehy-

drated. If the lens is adhering to a surface, such as a

counter top, apply saline or rinsing solution before handling.

To rehydrate the lens:

• Handle the lens carefully.

• Place the lens in its storage case and soak the lens in a

recommended rinsing and storing solution for at least one

hour until it returns to a soft state.

• Clean and disinfect the rehydrated lens using a recom-

mended lens care system.

• If after soaking, the lens does not become soft, the lens

should not be used until examined by the eye care

practitioner.

CARE FOR A STICKING (NONMOVING) LENS

If the lens sticks (stops moving), the patient should be

instructed to use a lubricating or rewetting solution in their

eye. The patient should be instructed to not use plain water,

or anything other than the recommended solutions. The

patient should be instructed to contact the eye care practi-

tioner if the lens does not begin to move upon blinking after

several applications of the solution.

PRACTITIONER FITTING SETS

All lenses that have been opened must be disinfected after each

ﬁtting and at least once each week. Unopened lenses are sterile

and need not be disinfected until the vial seal has been broken.

EMERGENCIES

The patient should be informed that if chemicals of any kind

(household products, gardening solutions, laboratory chem-

icals, etc.) are splashed into the eyes, the patient should:

FLUSH EYES IMMEDIATELY WITH TAP WATER AND THEN

REMOVE LENSES PROMPTLY. CONTACT THE EYE CARE

PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM

WITHOUT DELAY.

HOW SUPPLIED

Each Optima™ Toric (heﬁlcon B) Contact Lens is supplied

sterile in a glass vial containing bicarbonate buffered saline

solution. The container is marked with the manufacturing lot

number of the lens, the base curve, sphere power, cylinder

power, axis, diameter and expiration date.

REPORTING OF ADVERSE REACTIONS

All serious adverse experiences and adverse reactions

observed in patients wearing BAUSCH & LOMB

Optima™ Toric (heﬁlcon B) Contact Lenses or experienced

with the lenses should be reported to:

Bausch & Lomb Incorporated

Rochester, New York 14603

Toll Free Telephone Number

In the Continental U.S., Alaska, Hawaii

1-800-828-9030

In New York State

1-800-462-1720

Optima

™

Toric

(heﬁlcon B)

Contact Lenses

IMPORTANT: This package insert is effective as of March

2000 and supersedes all prior inserts for the products

described below. Please read carefully and keep this

information for future use.

This package insert is intended for the eye care practitioner,

but should be made available to patients upon request. The

eye care practitioner should provide the patient with the

patient instructions that pertain to the patient’s prescribed

lens.

CAUTION: Federal (U.S.A.) Law Prohibits Dispensing

Without Prescription

Bausch & Lomb Incorporated

Rochester, NY 14603

BAUSCH & LOMB, OPTIMA, SENSTITIVE EYES, and ReNu are

trademarks of Bausch & Lomb Incorporated.

DPI0003-0300 Printed in U.S.A.

Optima Toric Insert / US / LYN

DPI0003-0300 5756

BLACK

1 2 3 4 5 6 7 8

Amy Werther - e: amy.r.werther@bausch.com - t: 585.338.5202 - f: 585.338.8959

1 2 3 4 5 6 7 8

(heﬁlcon B) 1
Contact Lenses 1