Bausch & Lomb SofLens 59 Contact Lenses User Manual

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PACKAGE INSERT/

FITTING GUIDE

(hilafilcon B)

Visibility Tinted Contact Lenses

for Daily Wear

CAUTION:

Federal (USA) Law restricts this device to
sale by or on the order of a licensed
practitioner.

IMPORTANT:

This package insert has been developed to provide practi­tioners with information covering characteristics of the
BAUSCH & LOMB
Tinted Contact Lens and to illustrate fitting procedures. It is

®

SofLens®59 (hilafilcon B) Visibility

effective as of April 2003 and supersedes all prior fitting
guides for the product described. Please read carefully and
keep this information for future use.

This package insert 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.

DESCRIPTION:

The BAUSCH & LOMB®SofLens®59 (hilafilcon B) Visibility
Tinted Contact Lens is a soft hydrophilic contact lens which
is available as a spherical lens. The lens is made from the
hilafilcon B material, a hydrophilic copolymer of 2-hydrox­yethyl methacrylate and N-vinyl pyrrolidone, and is 59%
water by weight when immersed in a sterile saline solution.
This lens is tinted blue with Reactive Blue Dye 246.

The physical / optical properties of the lens are:
Specific Gravity: 1.119

Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value – greater than 95 %
Water Content: 59%
Oxygen Permeability (Dk): 22 x10

-11

(sec x cm

[cm3O2(STP) x cm]/

2

x mmHg)@35°C

(Polarographic Method)

LENS PARAMETERS AVAILABLE

The BAUSCH & LOMB®SofLens®59 (hilafilcon B) Visibility

Contact Lens is a hemispherical shell of the following

Tinted
dimensions:

• Diameter (fT): 14.2mm

• Center Thickness (tc): 0.05mm to 0.75mm

• Base Curve: 8.6mm

• Powers - Spherical (F´v): -0.50D to -6.00D in .25D steps

-6.50D to -9.00D in .50D steps

+0.50D to +6.00D in.25D steps

HOW THE LENS WORKS (ACTIONS):

In its hydrated state, the BAUSCH & LOMB®SofLens®59
(hilafilcon B) Visibility Tinted Contact Lens when placed on
the cornea acts as a refracting medium to focus light rays
on the retina.

INDICATIONS

The BAUSCH & LOMB®SofLens®59 (hilafilcon B) Visibility
Tinted Contact Lens is indicated for the daily wear correction
of refractive ametropia (myopia and hyperopia) in aphakic
and/or not-aphakic persons with non-diseased eyes. The
lens may be prescribed in spherical powers ranging from
+20.00D to -20.00D.

Replacement schedules may vary from patient to patient,
and should be decided by eye care professionals in consul­tation with their patients. The 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.

CONTRAINDICATIONS (REASONS NOT TO USE):

DO NOT USE the BAUSCH & LOMB®SofLens®59 (hilafilcon
B) 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
Contact Lens

SofLens®59 (hilafilcon B) Visibility Tinted

• 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 could result in

to the eye. It is essential that patients follow their

injury

serious

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

• 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

loss of vision.

of serious adverse reactions is increased when daily wear
lenses are worn overnight.

• The need for strict compliance with the care regimen
including cleaning of the lens case, wearing restrictions,

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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
promptly contact his or her eye care professional.

immediately remove lenses and

PRECAUTIONS:

Special Precautions for Eye Care Professionals:

• 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
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 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.

• Patients who wear aspheric contact lenses, such as the

BAUSCH & LOMB
may not achieve the best corrected visual acuity for either

®

SofLens®59, to correct presbyopia

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.

• 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 dispos
able lenses and lenses worn on a frequent/planned
replacement schedule after the recommended wearing
schedule prescribed by the eye care professional.

• 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 follow­up schedule.

• Aphakic patients should not be fitted with BAUSCH &

®

SofLens®59 Contact Lenses until the determina-

LOMB
tion 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 SofLens
from BAUSCH & LOMB® and understand its contents prior

®

59 Patient Information Booklet available

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 SofLens® 59
Contact Lenses 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:

• 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.

• 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.