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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.
 
DeviceBIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF 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 NumberS013
Date Received01/18/2002
Decision Date03/11/2002
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 BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS). THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES WHICH MANIFEST MYOPIA (NEARSIGHTEDNESS), HYPEROPIA (FARSIGHTEDNESS) AND ASTIGMATIC CORRECTION LOWER THAN -2.00 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR OR EXTENDED WEAR. FOR EXTENDED WEAR, THE LENS MAY BE PRESCRIBED FOR UP TO 7 DAYS/6 NIGHTS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION; OR FOR DISPOSABLE WEAR AS DIRECTED BY THE EYE CARE PRACTITIONER. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES MAY BE PRESCRIBED FOR SINGLE USE DISPOSABLE WEAR OR FOR SCHEDULED REPLACEMENT WEAR, WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR SCHEDULED REPLACEMENT THE LENS MAY BE DISINFECTED USING A CHEMICAL (NOT HEAT) OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
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