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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPERVISION, INC.
370 woodcliff drive
suite 200
fairport, NY 14450-0000
PMA NumberP850079
Supplement NumberS047
Date Received12/28/2009
Decision Date05/03/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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