Bausch & Lomb Silsoft and Silsoft Super Contact Lenses User Manual
Page 2

or a corneal specialist immediately if they experience any
symptoms such as those listed below under Adverse
Effects. (Practitioners examining patients presenting such
symptoms should see below Important Treatment
Information for Adverse Effects.)
Extended Wear: The risk of ulcerative keratitis has been
shown to be greater among users of extended wear
contact lenses than among users of daily wear contact
lenses. The risk among extended wear lens users
increases with the number of consecutive days that the
lenses are worn between removals, beginning with the
first overnight use. Some researchers believe that these
complications are caused by one or more of the following:
a weakening of the cornea’s resistance to infections,
particularly during a closed-eye condition, as a result of
hypoxia; an eye environment which is somewhat more
conductive to the growth of bacteria and other microor-
ganisms, particularly when a regular periodic lens removal
and disinfection or disposal schedule has not been
adhered to by the patient; improper lens disinfection or
cleaning by the patient; contamination of lens care
products; poor personal hygiene by the patient; patient
unsuitability to the particular lens or wearing schedule;
accumulation of lens deposits; damage to the lens;
improper fitting; length of wearing time; and the presence
of ocular debris or environmental contaminants.
Additionally, smoking increases the risk of ulcerative
keratitis in contact lens users.
While the great majority of patients successfully wear
contact lenses, extended wear of lenses also is reported
to be associated with a higher incidence and degree of
epithelial microcysts and infiltrates, and endothelial
polymegathism, which require consideration of
discontinuation or restriction of extended wear.
The epithelial conditions have been seen to be reversible
upon discontinuation of lens wear. The reversibility of
endothelial effects of contact lens wear has not yet been
established. As a result, practitioner’s views of extended
wearing times vary from not prescribing extended wear at
all to prescribing flexible wearing times from occasional
overnight wear to prescribing extended wearing periods
from 1 to 7 days for cosmetic extended wear and from 1
to 30 days for aphakic extended wear with specified
intervals of no lens wear for certain patients, with
follow-up visits, and with a proper care regimen.
PRECAUTIONS
In prescribing contact lenses, the Precautions should be
carefully observed. It is also strongly recommended that
the practitioner review with the patient the Patient
Information Booklet available from Bausch & Lomb prior
to dispensing the lenses and assure that the patient
understands its contents.
• Contact lens wear may not be suitable for certain
occupations, or, in other instances, may require eye
protection equipment.
• Environmental fumes, smoke, dust, and vapors, and
windy conditions, must be avoided, in order to minimize
the chances of lens contamination or physical trauma to
the cornea.
• Hard contact lens solutions not indicated for use with
SILSOFT Lenses may not be used n the SILSOFT Lens
Care System. If a SILSOFT Lens is worn after soaking
in a hard contact lens solution, serious corneal injury
may result.
• Chemical disinfection solution may not be used with
heat unless specifically indicated in the labeling for heat
and chemical disinfection.
• Bausch & Lomb recommends that sterile solutions be
used in the SILSOFT Lens Care System. Sterile non-
preserved solutions should be used if the patient is
allergic to preservatives. When used, sterile non-
preserved solutions must be discarded after the time
specified in their label directions.
• Eye injury from irritation or infection and damage to
lenses may result if cosmetics, lotion, soaps, creams,
hair sprays or deodorants come in contact with lenses.
• Eye injury from irritation or infection may result from
lens contamination.
• Tweezers or other tools should not be used by patients
to remove a lens from the lens container. The lens
should be poured into the hand.
• Patients must be instructed on and demonstrate the
ability of prompt removal of the lenses.
• Aphakic patients should not be fitted with contact lenses
during the post operative period until, in the opinion of
the surgeon, the eye has healed completely.
• A lens must move freely on the eye for a proper fit. For
further information, see the BAUSCH & LOMB
®
SILSOFT
®
(elastofilcon A) Fitting Guide.
• Some patients will not be able to tolerate extended wear
even if able to tolerate the same or another lens on a
daily wear basis. Patients should be carefully evaluated
for extended wear prior to prescription and dispensing,
and practitioners should conduct early and frequent
follow-up examinations to determine ocular response to
extended wear.
• When BAUSCH & LOMB SILSOFT (elkastofilcon A)
Contact Lenses are worn by persons who subsequently
require topical medications to be administered to the
eye, the lenses should be removed and cleaned and
disinfected prior to being inserted after using
medication. No medication or solutions except those
prescribed by the eye physician should be used.
• After removal of lenses from the lens case, to prevent
contamination and to help avoid serious eye injury,
always empty and rinse lens case with fresh rinsing
solution and allow to air dry between each lens
disinfection cycle.
ADVERSE EFFECTS
The following symptoms may occur:
• eye pain
• eyes sting, burn, or itch (irritation)
• comfort is less than when lens was first placed on eye