Bausch & Lomb Boston Multivision GP Contact Lenses - Manual

P RO F E S S I O N A L
FITTING AND
I N F O R M AT I O N
G U I D E
BOSTON® MultiVision
(enflufocon A) Contact Lens
Rigid Gas Permeable
Contact Lenses for Daily Wear
TABLE OF CONTENTS
Introduction
Product Description
Lens Parameters Available
Indications
Contraindications, Warnings, Precautions,
and Adverse Reactions
Selection of Patients
Pre-Fitting Examination
Fitting Guide
In-Office Care of Trial Lenses
Recommended Initial Wearing Schedule
Clinical Assessment
Criteria of a Well-fitted Lens
Optimizing Fitting Characteristics
Problem Solving
Modified Monovision Fitting Guidelines
Patient Lens Care Directions
Laboratory Lens Cleaner
Care for a Sticking (Non-Moving) Lens
Reporting of Adverse Reactions
How Supplied
INTRODUCTION
Boston® MultiVision (enflufocon A) Contact Lenses are made from the Boston ES® (enflufocon A)
fluoro silicon acrylate material with a water content of <1% by weight.
For a complete listing of a vailable lens parameters, please refer to LENS PARAMETERS AVAILABLE.
PRODUCTDESCRIPTION
The Boston ES® (enflufocon A) is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer
including a color additive (D &C Green No . 6) with an ultraviolet absorber (Uvinul D-49).
The lenses described above can have a center thickness of 0.10 to ~0.69 mm that will vary with lens design and
power.
The physical/optical properties of the lens are:
Specific Gravity 1.22
Refractive Index 1.443
Light Absorbance (640 nm) 10.2 (absorbance units/inch)
Surface Character Hydrophobic
Wetting Angle 52°
Water Content <1%
Oxygen Permeability 36* (18**)
{x 10 -11 (cm 3 O
2 •
cm)/(cm 2 • sec • mmHg) @ 35° C}
*gas to gas method
**polarographic method (ISO/Fatt)
LENS PARAMETERS AVAILABLE
Power Range -20.00D to +20.00D
in 0.12D increments
Diameter 9.6 mm
Base Curve Range 7.30 mm to 8.30 mm
in 0.1 mm increments
Add Powers Nominal Add Power
+1.50 D
B O S TON® ES - 0.07 mm thick BOSTON ES (Blue)
CORNEA - Human cornea from a 24-year-old person as described in Lerman, S., Radiant Energy and the Eye,
MacMillan, New Yo rk, 1980, p. 5 8 .
C RY S TALLINE LENS - Human crystalline lens from a 25-year-old person as described in Wa x l e r, M., Hitchins,
V.M., Optical Radiation and Visual Health, CRC P r e s s, Boca Raton, Florida, 1986, p. 19, figure 5.
NOTE
The effectiveness of wearing UV-absorbing contact lenses in preventing or reducing the incidence of ocular disor-
ders associated with exposure to UV light has not been established at this time.
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.
INDICATIONS
The BOSTON® MultiVision (enflufocon A) Contact Lens is indicated for daily wear for the correction of refractive
ametropia (myopia, hyperopia, astigmatism and presbyopia) in not aphakic persons with non-diseased eyes, who
exhibit astigmatism of 4.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nomi -
nal functional add of +1.50 diopters. The lens may be disinfected using a chemical disinfecting system only.
CONTRAINDICATIONS (REASONSNO T TO USE)
DO NOT USE the BOSTON® MultiVision (enflufocon A) 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 not aphakic
• 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®MultiVision (enflufocon A)
Contact Lenses
• Any active corneal infection (bacterial, fungal, or viral)
• Red or irritated eyes
WARNINGS
Patients should be advised of the fo l l owing wa rnings pertaining to contact lens we a r:
• Problems with contact lenses and lens care products could result in serious injury to the eye. It is essential that
patients follow their eyecare practitioner’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 patients should be instructed not to wear lenses
while sleeping.Clinical studies have shown that the risk of serious adverse reactions is increased when daily
wear lenses are worn o vernight.
• Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions
than nonsmokers.
Practitioner Note: BOSTON® MultiVision
( e n f l u focon A) Contact Lenses are not sterile when shipped from the Authorized BOSTONManufacturer. Prior to
dispensing, clean and disinfect the lens(es) according to the appropriate lens care regimen.
• If a patient experiences e ye discomfort, excessive tearing, vision changes, or redness of the e ye, the patient
should be instructed to immediately remo ve lenses and promptly contact his or her eyecare practitioner.
PRECAUTIONS
•Special Precautions for Eyecare Practitioners:
• 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 e yecare practitioner should con-
sider all characteristics of the lens that can affect lens performance and ocular health, including oxygen perme-
ability, wettability, central and peripheral thickness.
• 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 perform-
ance on the eye should be carefully monitored by the prescribing eyecare practitioner.
• Before leaving the eyecare practitioner’s office, the patient should be able to properly remo ve lenses or should
have someone else available who can remove the lenses for him or her .
• Eyecare practitioners should instruct the patient to remove the lenses immediately if the e ye becomes red or
irritated.
• The presence of the ultr aviolet (UV) light absorber in the BOSTON® MultiVision (enflufocon A)l contact lens
material may require equipment enhancement to visualize fluorescein patterns adequately. (Refer to the FIT-
TING PROCEDURE for detailed instructions.)
Eyecare 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.