Bausch & Lomb Silsoft and Silsoft Super Contact Lenses - Manual

SILSOFT ®
(elastofilcon A)
Contact Lenses For Aphakic Daily
and Extended Wear
IMPORTANT:
This package insert is effective as of February, 1995 and
supersedes all prior inserts for the products described
below. Please read it carefully and keep this information
for future use.
CAUTION:
Federal Law Prohibits Dispensing Without Prescription.
VISION CORRECTION USE
For BAUSCH & LOMB
® SILSOFT ® (elastofilcon A) Contact
Lenses For Aphakic Daily and Extended Wear.
DESCRIPTION:
For BAUSCH & LOMB
® SILSOFT ® (elastofilcon A) Contact
Lenses are available as spherical lenses. These lenses are
hemispherical flexible shells of the following dimensions:
• Chord diameter:
11.3mm to 12.5mm
• Center Thickness: Plus lenses vary in center
thickness according to
power with thickness always
kept to a minimum.
• Powers: See "Indications"
The lens material is a dimethyl diphenyl methylvinyl
polysiloxane.
The physical properties of the lens are:
Specific Gravity: 1.13 + 0.03
Refractive Index: 1.44 + 0.02
Light Transmission: Measures greater than
85% - dry
Surface Character: Hydrophilic
Water Content:
Approximately 0.2%
*Oxygen Permeability: 340 x 10 -11 (cm 3 –cm/cm 2 –
sec. –mmHg) at 21°C.
*ASTM D143475 Method
INDICATIONS
Daily Wear
For BAUSCH & LOMB
® SILSOFT ® (elastofilcon A) Contact
Lenses are indicated for vision correction use in aphakic
patients with nondiseased eyes who exhibit refractive
astigmatism of 1.50 diopters or less and corneal
astigmatism of 2.00 diopters or less and can obtain
satisfactory visual acuity, in a power range of +7.00 to
+35.00 diopters.
Extended Wear
For BAUSCH & LOMB
® SILSOFT ® (elastofilcon A) Contact
Lenses are indicated for extended wear as prescribed by
the eye care practitioner for continuous use up to a
maximum of 30 days between removals for cleaning and
disinfecting. (However, see the "WARNINGS" reference to
the relationship between the lens wearing schedule and
corneal complications.) The lenses are indicated for the
correction of visual acuity in aphakic persons with non-
diseased eyes who exhibit refractive astigmatism of 1.50
diopters or less and corneal astigmatism of 2.00 diopters
or less and can obtain satisfactory visual acuity, in a
power range of +7.00 to +35.00 diopters.
Note: Supplemental spectacles may be required for
aphakic persons in some conditions to provide near vision
or to compensate for uncorrected refractive astigmatism.
CONTRAINDICATIONS
BAUSCH & LOMB
® SILSOFT ® (elastofilcon A) Contact
Lenses are contraindicated when any of the following
conditions exist:
• Inflammation in the anterior chamber of the eye
• Active disease, injury or abnormality affecting the
cornea, conjunctiva, or eyelids.
• Microbial infection of the eye
• Insufficiency of lacrimal secretion
• Corneal hypoesthesia
• Use of a medication that is contraindicated, including
eye medications.
• Patient history of reoccurring eye or eyelid infections
including sties, or of adverse effects associated with
contact lens wear, or of intolerance or abnormal ocular
response to contact lens wear.
• History of patient non-compliance with contact lens
care and disinfection regimens, wearing restrictions,
wearing schedule, or follow-up visit schedule.
• Patient inability or unwillingness, because of age,
infirmity, or other mental or physical conditions, or an
adverse working or living environment, to understand or
comply with any warnings, precautions, restrictions, or
directions.
WARNINGS
Serious eye injury and loss of vision may result from
problems associated with wearing contact lenses and
using contact lens care products. Therefore, after a
thorough eye examination, including appropriate medical
background, patients must be fully apprised by the
prescribing practitioner of all the risks associated with
contact lens wear. To minimize these risks, the need for
strict compliance with the care and disinfection regimen
including cleaning of the lens case, wearing restrictions,
wearing schedules, and follow-up visit schedule must be
emphasized to the patient. (See the considerations listed
under Contraindications and Precautions.)
Since eye injury can develop rapidly, it is most important
that patients be instructed in the possible signs or
symptoms of problems and need to remove the lenses
and be examined by the prescribing eye care practitioner