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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.
 
DeviceHYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantTHE COOPER COMPANIES
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS011
Date Received07/20/2001
Decision Date01/16/2002
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
Approval Order Statement  
APPROVAL FOR THE HYDROGENICS 60 (OCUFILCON F) UV IN-MONOMER TINT CONTACT LENS INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATIONS: SPHERICAL: HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM UP TO 2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. TORIC: HYDROGENICS (OCUFILCON F) UV BLOCKING CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO -6.00 DIOPTERS. THE OVERALL POWER RANGE IS +8.00D TO -10.00D SPHERE AND PL TO -6.00D CYLINDER. THE LENS MAY BE PRESCRIBED FOR DAILY OR EXTENDED WEAR IN NOT-APHAKIC PERSONS. WHEN PRESCRIBING FOR EXTENDED WEAR, THE EYE CARE PRACTITIONER MAY RECOMMEND LENS WEAR UP TO 7 DAYS / 6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENS FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULES REPLACEMENT. WHEN PRESCRIBING FOR SCHEDULED REPLACEMENT WEAR, THE CONTACT LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) DISINFECTING SYSTEM. HYDROGENICS 60 (OCUFILCON F) UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
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