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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.
 
DeviceSOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP960022
Supplement NumberS003
Date Received03/03/2003
Decision Date04/04/2003
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A TORIC DESIGN WITH AN EXTENDED WEAR INDICATION FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR THE ABOVE REFERENCED DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB SOFLENS66 TORIC (ALPHAFILCONA) VISIBILITY TINTED CONTACT LENSES AND IS INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BY THE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA AND ASTIGMATISM) IN NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF UP TO 5.00 DIOPTERS (D) THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +6.00 D TO -9.00D WHEN PRESCRIBED FOR USE TO 7 DAYS OF EXTENDED WEAR.
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