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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.
 
DeviceVISTAKON (SENOFILCON A) CONTACT LENS MATERIAL
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
7500 CENTURION PARKWAY
SUITE 100 - ERCA
JACKSONVILLE, FL 32256
PMA NumberP040045
Supplement NumberS001
Date Received04/23/2007
Decision Date08/14/2007
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL INDICATION FOR THERAPEUTIC USE FOR THE VISTAKON (SENOFILCON A) CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACUVUE OASYS BRAND CONTACT LENSES WITH HYDRACLEAR PLUS (SENOFILCON A) AND IS ADDITIONALLY INDICATED FOR THERAPEUTIC USE AS A BANDAGE LENS FOR THE FOLLOWING ACUTE AND CHRONIC CONDITIONS:1) FOR CORNEAL PROTECTION IN LID AND CORNEAL ABNORMALITIES SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS AND RECURRENT CORNEAL EROSION. IN ADDITION IT IS INDICATED FOR PROTECTION WHERE SUTURES OR OCULAR STRUCTURE MALFORMATION, DEGENERATION OR PARALYSIS MAY RESULT IN THE NEED TO PROTECT THE CORNEA FROM EXPOSURE OR REPEATED IRRITATION. 2) FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, AND POST-KERATOPLASTY. 3) FOR USE AS A BARRIER DURING THE HEALING PROCESS OF EPITHELIAL DEFECTS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC AND NEUROPARALYTIC KERATITIS, AND CHEMICAL BURNS. 4) FOR POST SURGICAL CONDITIONS WHERE BANDAGE LENS USE IS INDICATED SUCH AS POST REFRACTIVE SURGERY, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL OCULAR SURGICAL CONDITIONS. 5) FOR STRUCTURAL STABILITY AND PROTECTION IN PIGGY BACK LENS FITTING WHERE THE CORNEA AND ASSOCIATED SURFACES ARE TOO IRREGULAR TO ALLOW FOR CORNEAL RIGID GAS PERMEABLE (RGP) LENSES TO BE FIT. IN ADDITION THE USE OF THE LENS CAN PREVENT IRRITATION AND ABRASIONS IN CONDITIONS WHERE THERE ARE ELEVATION DIFFERENCES IN THE HOST/GRAPH JUNCTION OR SCAR TISSUE. LENSES PRESCRIBED FOR THERAPEUTIC USE MAY BE WORN FOR DAILY OR EXTENDED WEARING PERIODS.
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