3
C O N T R A I N D I C A T I O N S ( R E A S O N S N O T T O U S E )
DO NOT USE the VISTAKON
®
(galyfilcon A) Contact Lens when any of the following conditions exist:
•
Acute and 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 use of contact lens solutions
•
Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is to be
used to care for the VISTAKON
®
(galyfilcon A) Contact Lens
•
Any active corneal infection (bacterial, fungal, protozoal or viral)
•
If eyes become red or irritated
W A R N I N G S
Problems with contact lenses could result in serious injury to the eye. Proper use and care of contact
lenses and lens care products, including lens cases, are essential for the safe use of these products. The
following warnings pertain to contact lens wear.
Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. The results of a study
1
indicate the following:
•
The overall annual incidence of ulcerative keratitis in daily wear contact lens users is estimated to be
about 4.1 per 10,000 persons and about 20.9 per 10,000 persons in extended wear contact lens
users.
•
The risk of ulcerative keratitis is 4 to 5 times greater for extended wear contact lens users than for
daily wear users. When daily wear users who wear their lenses overnight and extended wear users
who wear their lenses on a daily basis are excluded from the comparison, the risk among extended
wear users is 10 to 15 times greater than among daily wear users.
•
When daily wear users wear their lenses overnight (outside the approved indication), the risk of ulcer-
ative keratitis is 9 times greater than among those who do not wear them overnight.
1 New England Journal of Medicine, September 21, 1989
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