Bausch & Lomb Optima Toric User Manual

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.