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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBIOFINITY (COMFILCON A)
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCOOPERVISION MANUFACTURING, LTD.
PMA NumberP080011
Date Received04/07/2008
Decision Date11/19/2008
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 08M-0608
Notice Date 11/26/2008
Advisory Committee Ophthalmic
Clinical Trials NCT00597467
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the biofinity (comfilcon a) soft contact lens. This device is indicated for use as follows: biofinity (comfilcon a) sphere and aspherc soft contact lenses are indicated for the correction of ametropia (myopia and 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 by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere withvisual acuity. Biofinity (comfilcon a) toric soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 diopters and astigmatic corrections from -0. 25 to -5. 00 diopters. Biofinity (comfilcon a) multifocal soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20. 00 to +20. 00 diopters with add powers from +0. 50 to +3. 00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity. Biofinity (comfilcon a) contact lenses may be prescribed for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a daily wear schedule prior to overnight wear. The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
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