• Always remove, clean, rinse, and disinfect lenses
according to the schedule prescribed by the eye
care practitioner. The use of a cleaning solution
does not substitute for disinfection.
The lens care products listed below are recom-
mended by Polymer Technology for use with the
Boston EQUALENS II Contact Lens. Eye care practi-
tioners may recommend alternate products that
are appropriate for the patient’s use with his or
her lens(es).
LENS CARE TABLE
Product
Lens Care System
Purpose
Chemical (Not Heat)
Clean
Boston ADVANCE
®
Cleaner or
Boston
®
Cleaner
Disinfect
Boston ADVANCE
®
Comfort
Formula Conditioning Solution
or Boston
®
Conditioning
Solution
Store
Boston ADVANCE
®
Comfort
Formula Conditioning Solution
or Boston
®
Conditioning
Solution
Multi-Action
Boston SIMPLUS
™
Multi-Action
Solution or
Boston SIMPLICITY
®
Multi-
Action Solution
Lubricate/Rewet
Boston
®
Rewetting Drops
Weekly
Boston
®
ONE STEP
Enzymatic
Liquid Enzymatic Cleaner
Cleaner
•
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 mix-ups), rinse the lens thoroughly
as directed by your eye care practitioner 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, disinfect lenses using the sys-
tem recommended by the manufacturer
and/or the eye care practitioner. Follow the
instructions provided in the disinfecting solu-
tion packaging.
• To store lenses, disinfect and leave them in the
closed/unopened case until ready to wear. If
lenses are not to be used immediately follow-
ing disinfection, the patient should be
instructed to consult the package insert or the
eye care practitioner for information on storage
of lenses.
• After removing the lenses from the lens case,
empty and rinse the lens storage case with
solutions as recommended by the lens case
manufacturer or the eye care practitioner; then
allow the lens case to air dry. When the case
is used again, refill it with storage solution.
The Boston EQUALENS II Contact Lenses are indi-
cated for daily wear or extended wear. The maxi-
mum suggested wearing time for these lenses is:
DAILY WEAR (DURING WAKING HOURS)
The suggested daily wear schedule for Boston
EQUALENS II Contact Lens is:
DAY
WEARING TIME (Hours)*
1
4 to 8 hours
2
6 to 10 hours
3
8 to 14 hours
4
10 to 15 hours
5
12 to All Waking Hours
6 and after
All Waking Hours
*if the lenses continue to be well-tolerated.
Lenses should be removed daily for cleaning and
disinfecting for 4 hours (or overnight) before
wearing.
EXTENDED WEAR (OVERNIGHT)
The suggested wearing schedule for Boston
EQUALENS II Contact Lens for extended wear is to
initially adapt to daily wear during the first week of
wear as described above. During the second week,
the patient should comfortably wear the lenses
during all waking hours. Then;
DAY
WEARING TIME (Hours)*
15-21
24 hours a day
*if the lenses continue to be well-tolerated.
The maximum suggested wearing time for Boston
EQUALENS II Contact Lenses extended wear is 1
week (7 days). Lenses should be removed for clean-
ing and disinfecting for 8-10 hours (overnight) at
the end of 1 week of extended wear, or more fre-
quently depending on the overall patient tolerance.
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
(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,
chemical (not heat) and carefully follow instruc-
tions on solution labeling. Different solutions
often cannot be used together, and not all solu-
tion are safe for use with all lenses.
Do not alter-
nate or mix lens care systems unless
indicated on solution labeling or if advised
by the eye care practitioner.
• Do not use saliva or anything other than the rec-
ommended solutions for lubricating or rewetting
lenses. Do not put lenses in the mouth.
• Lenses should be
cleaned, rinsed, and disin-
fected
each time they are removed.
Cleaning
and rinsing
are necessary to remove mucus and
film from the lens surface.
Disinfecting
is neces-
sary to destroy harmful germs.
© Polymer Technology, a Bausch & Lomb company
1400 North Goodman Street
Rochester, NY 14609
1-800-333-4730
® denotes registered trademarks of Polymer
Technology, a Bausch & Lomb compamy
Print date: 01/04 LB9197/06
Replace lens case at regular intervals as recom-
mended by the lens case manufacturer or your
eye care practitioner.
• Eye care practitioners may recommend a lubri-
cating/rewetting solution which can be used
to wet (lubricate) lenses while they are being
worn to make them more comfortable.
• Eye care practitioners may recommend a
weekly enzymatic cleaner which can be used to
effectively remove protein deposits from
Boston EQUALENS II Contact Lenses.
• Boston EQUALENS II Contact Lenses
cannot
be
heat (thermally) disinfected.
LENS CASE CLEANING AND MAINTENANCE
Contact lens cases can be a source of bacterial
growth. Lens cases should be emptied, cleaned,
rinsed with solutions recommended by the lens
case manufacturer or the eye care practitioner,
and allowed to air dry. Lens cases should be
replaced at regular intervals as recommended
by the lens case manufacturer or the eye care
practitioner.
CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving/cannot be
removed), the patient should be instructed to apply
one to three drops of a recommended lubricating
or rewetting solution directly to the eye and wait
until the lens begins to move freely on the eye
before removing it. If nonmovement of the lens
continues after 5 minutes, the patient should
immediately consult the eye care practitioner.
EMERGENCIES
The patient should be informed that if chemicals
of any kind (household products, gardening solu-
tions, laboratory chemicals, etc.) are splashed into
the eyes, the patient should: FLUSH EYES IMMEDI-
ATELY WITH TAP WATER, THEN REMOVE LENSES
PROMPTLY, IF POSSIBLE, AND IMMEDIATELY CONTACT
THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL
EMERGENCY ROOM WITHOUT DELAY.
HOW SUPPLIED
Each lens is supplied (nonsterile) in a plastic lens
storage case. The case is labeled with the base
curve, diopter power, diameter, center thickness,
color, UV-absorber and lot number.
REPORTING OF ADVERSE REACTIONS
All serious adverse reactions observed in patients
wearing Boston EQUALENS II Contact Lenses or
adverse experiences with the lenses should be
reported to:
Consumer Affairs
Polymer Technology, a Bausch & Lomb company
1400 North Goodman Street
Rochester, NY 14609
1-800-333-4730
• 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 dam-
aged, 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,
immediately remove the
lenses and consult the eye care practitioner.
When any of the above problems occur, a serious
condition such as infection, corneal ulcer, neovas-
cularization, or iritis may be present. The patient
should be instructed to
keep the lens off the eye
and seek immediate
professional identification
of the problem and prompt treatment to avoid
serious eye damage.
FITTING
Conventional methods of fitting contact lenses
apply to Boston EQUALENS II (oprifocon A) Contact
Lenses. For a detailed description of the fitting
techniques, refer to the Boston EQUALENS II
Professional Fitting and Information Guide, copies
of which are available from:
Practitioner Marketing Representative
Polymer Technology, a Bausch & Lomb company
1400 North Goodman Street
Rochester, NY 14609
1-800-225-1241
Professional Fitting Guides are also available
through your Authorized Boston Manufacturer.
WEARING SCHEDULE
The wearing and replacement schedules
should be determined by the eye care practi-
tioner.
Patients tend to overwear the lenses ini-
tially. The eye care practitioner should emphasize
the importance of adhering to the initial maximum
wearing schedule. Regular checkups, as determined
by the eye care practitioner, are also extremely
important.
health of the patient and lens performance on
the eye should be carefully monitored by the
prescribing eye care practitioner.
• Patients who wear 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 appropri-
ate type of lens for each patient.
• Aphakic patients should not be fitted with Boston
EQUALENS II Contact Lenses until the determina-
tion is made that the eye has healed completely.
• 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.
• The presence of the ultraviolet (UV) light absorber
in the Boston EQUALENS II Contact Lens material
may require equipment enhancement to visualize
fluorescein patterns adequately. (Refer to the
Fitting Guide for detailed instructions.)
Eye care practitioners should carefully instruct
patients about the following care regimen and
safety precautions:
• Different solutions often cannot be used
together, and not all solutions are safe for use
with all lenses. Use only recommended solutions.
– Do not heat the wetting/soaking solution
and/or lenses. Keep them away from extreme
heat.
– Always use
fresh unexpired
lens care
solutions.
– Always follow directions in the package inserts
for the use of contact lens solutions.
– Use only a chemical (not heat) lens care system.
Use of a heat (thermal) care system can warp
the Boston EQUALENS II Contact Lenses.
– Do not use saliva or anything other than the
recommended solutions for lubricating or wet-
ting lenses.
– Always keep the lenses completely immersed in
the recommended storage solution when the
lenses are not being worn (stored). If dry stor-
age is desired to store the lenses for a longer
period of time, they must first be cleaned,
rinsed with water and carefully dried by blotting
with a soft lint-free tissue prior to being placed
in a clean, dry lens storage case. Ideally, these
lenses should be cleaned and disinfected prior
to insertion.
• 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 non-
movement of the lens continues, the patient
should be instructed to immediately consult his
or her eye care practitioner.
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.
DESCRIPTION
The Boston
®
EQUALENS
®
II Rigid Gas Permeable
Contact Lens material, oprifocon A, for daily wear
or extended wear is composed of methyl-methacrylate-
fluoroitaconate-siloxanyl copolymer with an ultravi-
olet absorber (Uvinul D-49). The lenses are available
in clear (untinted), blue, or green. The tinted lenses
contain the following color additives:
Color
Color Additive
Blue
D&C Green No. 6
Green
D&C Green No. 6
D&C Yellow No. 18
The Boston EQUALENS Contact Lens is a hemi-
spherical shell of the following dimensions:
• 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-based cosmetics are less likely
to damage lenses than oil-based products.
• Do not touch contact lenses with the fingers or
hands if the hands are not free of foreign materi-
als, as microscopic scratches on 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 Instructions for the
Boston EQUALENS II Contact Lens and those
prescribed by the eye care practitioner.
• Never wear lenses beyond the period recom-
mended 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 on hard surfaces.
• Avoid all harmful or irritating vapors and fumes
while wearing lenses.
• Ask your eye care practitioner about wearing
lenses during water activities and other sports.
• Inform your doctor (health care practitioner) that
you wear contact lenses.
• Never use tweezers or other tools to remove
lenses from the lens case unless specifically indi-
cated for that use. Pour the lens into the hand.
• Do not touch the lens with fingernails.
• Always contact your eye care practitioner before
using any medicine in the eyes.
• Always inform your employer that you wear con-
tact lenses. Some jobs may require use of eye
protection 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 EFFECTS
The patient should be informed that the following
problems may occur:
• Eyes stinging, burning, itching (irritation), or other
eye pain
• Comfort is less than when lens was first placed on
the eye
• Feeling of something in the eye such as a foreign
body, scratched area
• Excessive watering (tearing) of the eyes
• Unusual eye secretions
• Redness of the eyes
• Reduced sharpness of vision (poor visual acuity)
• Blurred vision, rainbows, or halos around objects
• 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
• 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
> 0.65 mm
Green
> 0.55 mm
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
The lenses described above can have a center thick-
ness of 0.07 to 0.65 mm that will vary with lens
design, power and diameter.
The physical/optical properties of Boston
EQUALENS II GP Material are:
Specific Gravity
1.24
Refractive Index
1.423
Light Absorption (640 nm)
10.0 Blue
Light Absorption (640 nm)
4.8 Green
(Absorbance Units/Inch)
Surface Character
Hydrophobic
Wetting Angle
30°
Water Content
<1%
Oxygen Permeability
127* (85**)
* Polymer Technology, Gas to Gas Method
{ x 10
-11
(cm
2
/sec) (mL O
2
x mmHg) ) @ 35° C}
**Polarographic Method (ISO/Fatt)
BOSTON EQUALENS II
- 0.07 mm thick Boston
EQUALENS II (Clear) Contact Lens/Material.
CORNEA
- Human cornea from a 24-year-old person
as described in Lerman, S., Radiant Energy and the
Eye, MacMillan, New York, 1980, p. 58.
CRYSTALLINE LENS
- Human crystalline lens from
a 25-year-old person as described in Waxler, M.,
Hitchins, V.M., Optical Radiation and Visual Health,
CRC Press, Boca Raton, Florida, 1986, p. 19, figure 5.
NOTE
Long term exposure to UV radiation is one of the
risk factors associated with cataracts. Exposure is
based on a number of factors such as environmen-
tal conditions (altitude, geography, cloud cover)
and personal factors (extent and nature of outdoor
actitivies). UV-absorbing contact lenses help pro-
vide protection against harmful UV radiation.
However, clinical studies have not been done to
demonstrate that wearing UV-absorbing contact
lenses reduces the risk of developing cataracts or
other eye disorders. Consult your eye care prati-
tioner for more information.
WARNING
UV-absorbing contact lenses are
NOT
substitutes
for protective UV-absorbing eyewear such as UV-
absorbing goggles or sunglasses. Persons should
continue to use their protective UV-absorbing
eyewear as directed.
ACTIONS
The Boston EQUALENS II Contact Lens when placed
on the human cornea, acts as a refracting medium
to focus light rays on the retina to improve visual
acuity. The toric lens provides a more even surface
over the highly uneven astigmatic cornea and thus
helps to focus light rays on the retina.
PACKAGE
INSERT
Boston
®
EQUALENS
®
II
(oprifocon A)
Extended Wear
Spherical & Aspherical
Rigid Gas Permeable
Contact Lenses for
Myopia & Hyperopia
in Not-Aphakic Persons
Daily Wear
Spherical, Aspherical, Toric,
Bifocal/Multifocal & Scleral
Rigid Gas Permeable
Contact Lenses for
Myopia, Hyperopia, Astigmatism
& Presbyopia in Aphakic and
Not-Aphakic Persons
IMPORTANT:
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 (USA) Law restricts this
device to sale by or on the order
of a licensed practitioner.
200
300
400
500
600
700
800
EQUALENS II
(Clean, Condition,
Disinfect, Rinse
and Cushion)
Spherical Lens Design
Power Range
-20.00D to +20.00D
(daily wear)
-20.00D TO +12.00D
(extended wear)
in 0.25D increments
Diameter
7.0 mm to 11.5 mm
Base Curve Range
5.00 mm to 9.00 mm
in 0.01 mm increments
Aspherical Lens Designs
(Some of these designs are patented;
manufacture of these lenses in Boston EQUALENS II
(oprifocon A) materials are authorized to
licensed labs only)
Power Range
-20.00D to +20.00D
(daily wear)
-20.00D TO +12.00D
(extended wear)
in 0.25D increments
Diameter
7.0 mm to 11.5 mm
Base Curve Range
6.00 mm to 9.20 mm
in 0.01 mm increments
Toric Lens Designs (Daily Wear)
Power Range
-20.00D to +20.00D
in 0.25D increments
Diameter
7.0 mm to 11.5 mm
Base Curve Range
6.80 mm to 9.50 mm
in 0.05 mm increments
Toricity
Up to 9.00 Diopters
Bifocal/Multifocal Lens Designs (Daily Wear)
(Some of these designs are patented;
manufacture of these lenses in Boston EQUALENS II
(oprifocon A) materials are authorized to
licensed labs only)
Power Range
-20.00D to +12.00D
in 0.25D increments
Diameter
8.5 mm to 11.5 mm
Base Curve Range
6.30 mm to 9.50 mm
in 0.01 mm increments
Segment Position
-2.00 mm to +1.00 mm
in 0.1 mm increments
Add Powers
+1.00D to +3.75D
in 0.25D increments
Prism Ballast
0.5 to 3.5 prism diopters
in 0.5D increments
Scleral Lens Designs (Daily Wear)
(Each clear tinted lens is designed to rest on
the external sclera and vault the cornea and
limbus thereby enclosing a compartment filled
with sterile, buffered non-preseved saline solu-
tion, which provides an aqueous environment
for and virtually neutralizes the optics of the
corneal surface.)
Power Range
-25.00D to +35.00D
in 0.25D increments
Diameter
16 mm to 26 mm
± 0.25 mm
Normalized Vaults
2.50 mm to 6.00 mm
± 0.1 mm
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.
