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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP010019
Supplement NumberS002
Date Received02/24/2003
Decision Date03/19/2003
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING INDICATION: NIGHT & DAY SOFT CONTACT LENSES ARE ALSO INDICATED FOR THERAPEUTIC USE. USE AS A BANDAGE TO PROTECT THE CORNEA AND TO RELIEVE CORNEAL PAIN DURING THE TREATMENT OF ACUTE OR CHRONIC OCULAR PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL EROSIONS, ENTROPION, CORNEAL EDEMA, AND CORNEAL DYSTROPHIES AS WELL AS POST-SURGICAL CONDITIONS RESULTING FROM CATARACT EXTRACTION AND CORNEAL SURGERY. NIGHT & DAY SOFT CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE OPTICAL CORRECTION DURING HEALING IF REQUIRED.
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