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
VISION CORRECTION USE
BAUSCH & LOMB® OptimaTMToric (hefilcon B) Contact
Lenses.
For: Nearsightedness (Myopia), Farsightedness (Hyperopia),
Astigmatism, Not-aphakic
DESCRIPTION
The BAUSCH & LOMB®OptimaTMToric (hefilcon B) Contact
Lens is a flexible shell with toric surfaces. The lens material,
(hefilcon B), is a hydrophilic random copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is
45% water by weight when immersed in a sterile saline
solution. The BAUSCH & LOMB
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
Water Content: 45%
Oxygen Permeability(Dk): 13x 10
®
OptimaTMToric (hefilcon B)
97%
–11
[cm3O2(STP) x cm]
2
/ (sec x cm
(Polarographic Method)
x mmHg)@35˚ C
ACTIONS
In its hydrated state, the BAUSCH & LOMB® OptimaTMToric
(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®OptimaTMToric (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®OptimaTMToric
(hefilcon B) 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
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®OptimaTMToric (hefilcon B) Contact Lens
(surround-
• 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 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 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 continuing 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 discolored. Whenever fluorescein is used, flush the eyes with
sterile saline solution. Wait at least 5 minutes before reinserting 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.
s
• - 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 discarded after the time specified in the labeling directions.
• - Do not use saliva or anything other than the recommended solutions for lubricating or wetting lenses.
• - Always keep the lenses completely immersed in the recommended 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
Do not get cosmetics, lotions, soaps, creams, deodorants,
handling lenses.
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 &
®
Optima™ Toric (hefilcon B) Contact Lens and
LOMB
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
•
Some jobs may require use of eye protection
wearer.
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
• 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 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 the eye care practitioner.
(tearing) of the eyes
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 infection, corneal ulcer, corneal vascularization, or iritis may be
present, and may progress rapidly. Less serious reactions
such as abrasions, epithelial stinging 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 amibiguous 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
gency, treated accordingly, and be referred to a corneal spe-
emer-
cialist 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.
FITTING
Conventional methods of fitting contact lenses apply to
BAUSCH & LOMB
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
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
®
Optima™ Toric (hefilcon B) Contact
®
Optima™ Toric (hefilcon B)
WEARING SCHEDULE
It is recommended that contact lens wearers see their eye
care practitioner twice each year or if directed, more frequently.
Daily Wear:
There may be a tendency for the daily wear patient to over
wear the lenses initially. Therefore, the importance of adhering 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 recommended 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
or
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 necessary 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 practitioner. 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
(hefilcon B) Contact Lenses; however, eye care practitioners
may recommend alternative products and procedures for
their patients. All components necessary for lens disinfection, cleaning and storage are available in BAUSCH &
®
Care Kits.
LOMB
Thermal Lens Care System
Action Care Product
Cleaning BAUSCH & LOMB
EYES
Rinsing, Disinfecting
& Storing Commercially available Heat
Disinfection Unit for Contact Lenses
used with:
BAUSCH & LOMB
Solution
BAUSCH & LOMB
EYES
BAUSCH & LOMB®SENSITIVE
EYES
BAUSCH & LOMB
EYES
Enzymatic Protein BAUSCH & LOMB
Removal Enzymatic Contact Lens Cleaner
BAUSCH & LOMB
Effervescent Enzymatic Contact
Lens Cleaner
BAUSCH & LOMB
Enzymatic Contact Lens Cleaner
®
Optima™ Toric
®
®
Daily Cleaner
®
Sterile Saline Spray
®
Saline Solution
®
Plus Saline Solution
SENSITIVE
®
ReNu®Saline
®
SENSITIVE
®
SENSITIVE
®
ReNu®Thermal
®
ReNu
®
SENSITIVE EYES
®
Chemical Lens Care System
Action Care Product
Cleaning BAUSCH & LOMB
Purpose Solution
BAUSCH & LOMB
Daily Cleaner
Disinfecting & BAUSCH & LOMB
®
ReNu®Multi-
®
SENSITIVE EYES
®
ReNu®Multi-
®
Storing Purpose Solution
®
Rinsing BAUSCH & LOMB
Purpose Solution
BAUSCH & LOMB®SENSITIVE EYES
Saline Solution
BAUSCH & LOMB
Solution
BAUSCH & LOMB
Sterile Saline Spray
BAUSCH & LOMB
Plus Saline Solution
Enzymatic Protein BAUSCH & LOMB
Removal Effervescent Enzymatic Contact
Lens Cleaner
BAUSCH & LOMB
Enzymatic Contact Lens Cleaner
BAUSCH & LOMB
ReNu®Multi-
®
ReNu® Saline
®
SENSITIVE EYES
®
SENSITIVE EYES
®
®
ReNu
®
SENSITIVE EYES
®
ReNu®1 Step
®
®
®
®
Enzymatic Contact Lens Cleaner
All Lens Care Systems
Action Care Product
Rewetting BAUSCH & LOMB
Rewetting Drops
BAUSCH &
®
Drops
®
®
ReNu
LOMB®SENSITIVE EYES
®
• 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 solution, 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
to be used immediately after disinfection, you should
lenses are not
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
to put on the eyes.
• Before reinsertion of the lenses, no rinsing is necessary
unless the eye care practitioner recommends rinsing.
ready
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 recommendations on the hydrogen peroxide system labeling.
• Thoroughly rinse lenses with a fresh solution recommended 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.
Enzyme cleaning does NOT replace routine cleaning and disinfecting. 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 recommended 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 rehydrated. 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 recommended 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 practitioner 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 chemicals, 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.
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
®
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.
Bausch & Lomb Incorporated
Rochester, NY 14603
© Bausch & Lomb Incorporated. All rights reserved worldwide.
BAUSCH & LOMB, OPTIMA, SENSTITIVE EYES, and ReNu are
trademarks of Bausch & Lomb Incorporated.
DPI0003-0300 Printed in U.S.A.
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