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INDICATIONS (USES)
Boston EQUALENS II (oprifocon A) RGP Contact Lens
is indicated for daily wear or extended wear from 1
to 7 days between removals for cleaning and disin-
fection as recommended by the eye care practi-
tioner. The lens is indicated for extended wear for
the correction of refractive ametropia (myopia and
hyperopia) in not-aphakic persons with non-dis-
eased eyes in powers from -20.00D to +12.00D.
The lens is indicated for daily wear for the correc-
tion of refractive ametropia (myopia, hyperopia,
astigmatism and presbyopia) in aphakic and not-
aphakic persons with non-diseased eyes.
The Boston Scleral (oprifocon A) RGP Contact Lens
for Daily Wear is indicated for eyes having signifi-
cantly reduced vision due to the presence of a dis-
torted corneal surface that:
1. precludes satisfactory spectacle lens correction
2. demonstrates significantly improved rigid con-
tact lens corrected vision
3. is incapable of wearing traditional corneal lenses
because of the inability to achieve adequate
lens centration/stability and/or tolerance to
physical contact with a lens.
Furthermore, eyes suffering from certain ocular
surface disorders may benefit from the physical
protection and the saline bath provided by a scleral
lens.
The lens may be disinfected using a chemical disin-
fection system only.
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE the Boston EQUALENS II Contact Lens
when any of the following conditions exist:
• Acute or 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 nonaphakic
• Any systemic disease that may affect the eye or
be exaggerated by wearing contact lenses
• Allergic reactions of ocular surfaces or adnexa
that may be induced or exaggerated by wearing
contact lenses or using contact lens solutions
• Allergy to any ingredient in a solution which
is to be used to care for the Boston EQUALENS II
Contact Lenses.
• Any active corneal infection (bacterial, fungal,
or viral)
• Red or irritated eyes
WARNINGS
Patients should be advised of the following warnings
pertaining to contact lens wear:
• Problems with contact lenses and lens care prod-
ucts could result in serious injury to the eye. It is
essential that patients follow their eye care prac-
titioner's directions 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 daily wear patients should be instructed
not to wear lenses while sleeping. Clinical studies
have shown that the risk of serious adverse reac-
tions is increased when these lenses are worn
overnight.
• 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.
• Studies have shown that contact lens wearers
who are smokers have a higher incidence of
adverse reactions than nonsmokers.
• The risk of ulcerative keratitis has been shown to
be greater among users of extended wear lenses
than among users of daily wear lenses. The risk
among extended wear lens users increases with
the number of consecutive days that lenses are
worn between removals, beginning with the first
overnight use. This risk can be reduced by care-
fully following directions for routine lens care,
including cleaning of the lens case. Additionally,
smoking increases the risk of ulcerative keratitis
for contact lens users.
• Clinical studies indicate that the majority of
patients who wish to wear Boston EQUALENS II
Contact Lenses for extended wear do so with
favorable results. However, suitability as an
extended wear patient should be discussed with
the eye care practitioner.
• All contact lens wearers must see their eye care
practitioner as directed. If the lenses are for
extended wear, the eye care practitioner may
prescribe more frequent visits.
PRECAUTIONS
Practitioner Note: Boston EQUALENS II Contact
Lenses are not sterile when shipped from the
Authorized Boston Manufacturer. Prior to dis-
pensing, clean and disinfect the lens(es) accord-
ing to the appropriate lens care regimen.
• Patients may experience a reduction in visibility while
wearing this lens in conditions of low illumination for
the following colors and center thicknesses:
Color
Center Thickness
Blue
Green
Special Precautions for Eye Care Practitioners:
• Due to the small number of patients enrolled in
clinical investigation of lenses, all refractive pow-
ers, design configurations, or lens parameters
available in the lens material are not evaluated
in significant numbers. Consequently, when
selecting an appropriate lens design and parame-
ters, 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
> 0.65 mm
> 0.55 mm
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