Bausch & Lomb Optima 38/SP User Manual
SOFLENS
®
(polymacon)
Contact Lenses
IMPORTANT:
This package insert is effective as of March 1997 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
For all BAUSCH & LOMB
®
SOFLENS®(polymacon)
Contact Lenses (including clear, visibility tinted,
cosmetically tinted, daily wear or extended wear polymacon
hydrophilic contact lenses)
SOFLENS includes the following types:
O3, O4, Occasions™ Multifocal, Optima™ 38, Optima™
38/SP, U3, U4, Sofspin™, HO3, HO4, B3, B4, P.A.1, F3,
H3, H4, N and NaturalTint
®
Contact Lenses
Spherical Lenses for: Nearsightedness (Myopia),
Farsightedness (Hyperopia), Presbyopia, Not-aphakic
and/or after Cataract Surgery (Aphakia)
DESCRIPTION
All Bausch & Lomb SOFLENS
®
(Clear and Visibility Tinted)
Contact Lenses are available as Spherical lenses. The lens
material (polymacon), is a hydrophilic polymer of
2-hydroxyethyl methacrylate, and is 38.6% water by
weight when immersed in saline solution. These lenses
are hemispherical flexible shells of the following
dimensions:
• Chord Diameter: 12.0mm to 18.0mm
• Center Thickness: 0.02mm to 1.0mm
• Posterior Apical Radius: 5.0mm to 12.0mm
• Powers (Spherical): See “Indications”
The physical/optical properties of the lens are:
Specific Gravity: 1.12
Refractive Index: 1.43
Surface Character: Hydrophilic
Water Content: 38.6%
Oxygen Permeability (Dk):* UNITS
SOFLENS
®
Contact Lens (clear) 8.4
SOFLENS
®
Visibility Tinted Contact Lens 8.5
NaturalTint
®
Contact Lens Average 9.3
Light Transmittance: C.I.E.** Y Value
SOFLENS
®
Contact Lens (Clear) - approximately 98%
SOFLENS
®
Visibility
Tinted Contact Lens - approximately 86%
to 98%
NaturalTint
®
Contact Lenses
Blue - approximately 82%
Aqua - approximately 84%
Green - approximately 76%
Brown - approximately 62%
*Dk = units x 10
-11
[cm3O2(STP) x cm]/(sec x cm2x
mm Hg) at 34°C (Polarographic Method)
**CIE light transmittance will differ by average thickness
across the optical zone for lenses tinted with Reactive
Blue 246.
SOFLENS
®
(polymacon) Visibility Tinted Contact Lenses
(including Occasions™ Multifocal, P.A.1, Sofspin,™ O3,
O4, Optima™ 38 and Optima™ 38/SP) are tinted blue
using Reactive Blue 246 or 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone to make the lens
more visible for handling purposes. The apparent color of
the SOFLENS
®
(polymacon) Visibility Tinted Contact
Lenses may decrease slightly following repeated
disinfection. This will not affect the safety or performance
of the lens.
NaturalTint
®
Contact Lenses are tinted with any of, or with
combinations of, the following lens colors: blue, green,
aqua, brown and yellow. These lenses are tinted with
synthetic dyes
(Blue) 7,16-Dichloro-6,15-dihydro-5,9,14,18anthrazinetetrone,
(Green) 16,17-Dimethoxydinaphtho[1,2,3-cd:3',2',1'lm]perylene-5,10-dione,
(Brown) 16,23-Dihydrodinaphtho[2,3-a:2',3'-i],
naphtho[2',3':6,7] indolo[2,3-c]carbazole5,10,15,17,22,24-hexone or
(Yellow) N,N'-(9,10-Dihydro-9,10-dioxo-1,5anthracenediyl)bisbenzamide) that impart colors to the
lens which combine with eye color to produce a natural
appearance.
ACTIONS
In its hydrated state, the BAUSCH & LOMB
®
SOFLENS
®
(polymacon) Contact Lens when placed on the cornea
acts as a refracting medium to focus light rays on the retina.
INDICATIONS (USES)
Daily Wear
The BAUSCH & LOMB
®
SOFLENS®(polymacon) Contact
Lenses are indicated for daily wear for the correction of
refractive ametropia (myopia and hyperopia) in aphakic
and/or non-aphakic persons with non-diseased eyes, that
exhibit astigmatism of 2.00 diopters or less and can
obtain satisfactory visual acuity, in a power range of
–20.00 to +20.00 diopters.
Occasions™ Multifocal and P.A.1 are indicated for daily
wear for the correction of refractive ametropia (myopia
and hyperopia) in phakic, presbyopic persons with nondiseased eyes, that exhibit astigmatism of 2.00 diopters
or less. The bifocal lens is indicated for patients requiring
up to 2.00 diopters of refractive add. The lens provides a
nominal functional add of 1.50 diopters in a power range
of –9.00 to +6.00 for Occasions™ Multifocal, and –6.00 to
+6.00 diopters for P.A.1.
NaturalTint
®
Contact Lenses are indicated for daily wear
for the correction of refractive ametropia (myopia and
hyperopia) in aphakic and/or non-aphakic persons with
non-diseased eyes, that exhibit astigmatism of 2.00
diopters or less and can obtain satisfactory visual acuity,
in a power range of –9.00 to +15.00 diopters. These may
also be used for color enhancement of the eye and for
ocular masking.
Eye care practitioners may prescribe the lenses for
traditional or frequent/planned replacement wear, with
cleaning disinfection and scheduled replacement (see
WEARING SCHEDULE). The lenses may be disinfected
using either a heat or chemical disinfection system.
Extended Wear
The Bausch & Lomb
®
SOFLENS®(polymacon) O3 and O4
Contact Lenses are indicated for extended wear from 1 to
7 days between removals for cleaning and disinfection or
replacement as recommended by the eye care practitioner.
The lenses are indicated for the correction of visual acuity
of myopic and hyperopic, phakic patients with nondiseased eyes, that exhibit astigmatism of 2.00 diopters
or less and can obtain satisfactory visual acuity in a
power range of –9.00 to +4.00 diopters.
Eye care practitioners may prescribe the lens for traditional
or frequent/planned replacement wear, with cleaning
disinfection and scheduled replacement (see WEARING
SCHEDULE). The lenses may be disinfected using either a
heat or chemical disinfection system.
CONTRAINDICATIONS (REASONS NOT TO USE):
DO NOT USE the BAUSCH & LOMB
®
SOFLENS
®
(polymacon) 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), if
non-aphakic
• 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® SOFLENS® (polymacon) Contact
Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS
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 these
lenses while sleeping. Clinical studies have shown that
the risk of serious adverse reactions is increased when
contact lenses are worn overnight.
• Studies have shown that contact lens wearers who are
smokers have a higher incidence of adverse reactions
than nonsmokers.
• NaturalTint
®
Contact Lenses reduce the amount of light
entering the eye and should not be used under reduced
illumination conditions such as night driving.
• As with all soft bifocal lenses, Occasions™ Multifocal
and P.A.1 Bifocal contact lenses may require a number
of fitting procedures before a final lens selection is
made. As a patient’s add requirement increases, the
probability of the patient achieving good visual acuity
decreases. A realistic visual expectation for the average
patient is that distance VA will be comparable to
spectacles; near VA probably slightly less.
EXTENDED WEAR
• The risk of ulcerative 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 epithelial polymegathism,
which require consideration of discontinuation or
restriction of extended wear. The epithelial conditions are
reversible upon discontinuation of extended wear.
The reversibility of endothelial effects of contact lens
wear has not been conclusively established. As a result,
practitioners’ 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 7 days
with specified intervals of no lens wear for certain
patients, with follow-up visits, and with a proper care
regimen. Some practitioners also recommend frequent
replacement of lenses at intervals such as one to two
weeks. Other practitioners may prescribe disposable
contact lens wear where lenses are disposed of at each
removal.
• 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’s
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 the eye should be carefully monitored
by the prescribing eye care practitioner.
• Patients who wear aspheric contact lenses to correct
presbyopia may not achieve the best corrected visual
acuity for either far or near vision. Visual requirements
vary with the individual and should be considered when
selecting the most appropriate type of lens for each
patient.
• 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 instruct the patient to
remove the lenses immediately if the eye becomes red
or irritated.
• Aphakic patients should not be fitted with SOFLENS
®
(polymacon) Contact Lenses until the determination is
made that the eye has healed completely.
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
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
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 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. Waterbase cosmetics are less likely to damage lenses than oilbase 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
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