Bausch & Lomb Optima 38/SP Contact Lenses - 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 [cm 3 O
2
(STP) x cm]/(sec x cm
2
x
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-methacry-
loxyethyl)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-5,9,14,18-
anthrazinetetrone,
(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]carbazole-
5,10,15,17,22,24-hexone or
(Yellow) N,N'-(9,10-Dihydro-9,10-dioxo-1,5-
anthracenediyl)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