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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantUNILENS CORPORATION USA
PMA NumberP960039
Date Received10/30/1996
Decision Date04/17/1997
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 97M-0272
Notice Date 07/08/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the soft-55 ew aphakic (vifilcon a) soft (hydrophilic) contact lenses for extended wear. This device is indicated for extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. The lenses are indicated for the correction of visual acuity in aphakic persons (after cataract surgery) that are myopic or hyperopic. Soft-55 ew aphakic lenses may be worn by persons who may exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity.
Supplements: S001 S002 S003 
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