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. |
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Device | CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P850079 |
Supplement Number | S047 |
Date Received | 12/28/2009 |
Decision Date | 05/03/2010 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE TRADE NAME CLEAR SOFT. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME CLEAR SOFT AND IS INDICATED FOR:CLEAR SOFT SPHERE (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BYPERSONS WHO EXHIBIT ASTIGMATISM OF -2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.CLEAR SOFT TORIC (METHAFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTIONOF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONSWITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS AND ASTIGMATICCORRECTIONS FROM -0.25 TO -5.00 DIOPTERS.THE CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HAVE BEEN APPROVED FOR EXTENDED WEAR FOR UP TO 6 NIGHTS/7 DAYS OF CONTINUOUS WEAR. IT ISRECOMMENDED THAT THE CONTACT LENS WEARER FIRST BE EVALUATED ON A DAILY WEAR SCHEDULE. IFSUCCESSFUL, THEN A GRADUAL INTRODUCTION OF EXTENDED WEAR CAN BE FOLLOWED AS DETERMINED BY THE PRESCRIBING EYE CARE PRACTITIONER.EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENS FOR FREQUENT REPLACEMENT WEAR WITH CLEANING, DISINFECTING AND SCHEDULED REPLACEMENTS. |
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