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Wearing restriCtions
Bausch + Lomb PureVision
(balafilcon A) Visibility Tinted Contact Lenses
described in this booklet should be removed from
your eyes for routine cleaning and disinfecting
as prescribed by your eye care professional. For
extended wear, once the lenses are removed,
your eyes should have a rest without lens wear
for at least one overnight, as recommended
by your eye care professional. Your eye care
professional will tell you how long to rest your eyes in
between wearing periods and will also recommend
a replacement period and appropriate lens care
products.
ContraindiCations
(reasons not to use)
DO NOT USE Bausch + Lomb PureVision
Astigmatism (balafilcon A) Visibility Tinted Contact
Lenses when any of the following conditions exist:
• A cute and subacute inflammation or infection of
the anterior chamber of the eye
• A ny eye disease, injury, or abnormality that affects
the cornea, conjunctiva, or eyelids
• S evere insufficiency of lacrimal secretion (dry eyes)
• C orneal hypoesthesia (reduced corneal sensitivity)
• A ny systemic disease that may affect the eye or be
exaggerated by wearing contact lenses
• A llergic reactions of ocular surfaces or adnexa
(surrounding tissue) that may be induced or
exaggerated by wearing contact lenses or use of
contact lens solutions
• A llergy to any ingredient, such as mercury or
Thimerosal, in a solution which is to be used to care
for Bausch + Lomb PureVision
(balafilcon A) Visibility Tinted Contact Lenses
• A ny active corneal infection (bacterial, fungal, or
viral)
• If eyes become red or irritated
Warnings
You should be aware of and fully discuss with your eye
care professional the following warnings pertaining to
contact lens wear:
• P roblems with contact lenses and lens care
products could result in serious injury to your
eye. It is essential that you follow your eye care
professional' s direction 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.
• Strict compliance with your lens care regimen
including cleaning of the lens case, wearing
restrictions, wearing schedule, and follow-up visit
schedule must be followed.
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• Studies have shown that contact lens wearers who
are smokers have a higher incidence of adverse
reactions than nonsmokers.
eXtended Wear:
• The risk of microbial keratitis has been shown to be
greater among users of continuous wear contact
lenses than among users of daily wear contact
lenses.
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 conducive to the growth of
bacteria and other microorganisms, particularly
when a regular periodic lens removal and
disinfecting 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.
While the great majority of patients successfully
wear contact lenses, continuous 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
continuous wear. The epithelial conditions are
reversible upon discontinuation of continuous wear.
The long term risk of microbial keratitis has
not been determined for this lens. A post-
approval study with average follow-up of 15
months has been completed.
• The reversibility of endothelial effects of contact
lens wear has not been conclusively established.
As a result, practitioners' views of continuous
wearing times vary from not prescribing continuous
wear at all to prescribing flexible wearing times
from occasional overnight wear to prescribing
continuous wearing periods from 1 to 30 days
with specified intervals of no lens wear for certain
patients, with follow-up visits, and with proper care
regimen.
• I f you experience eye discomfort, excessive
tearing, vision changes, or redness of the eye, you
should immediately remove lenses and promptly
contact your eye care professional.
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