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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 NameVISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
PMA NumberP040045
Date Received11/15/2004
Decision Date12/20/2005
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 05M-0504
Notice Date 12/27/2005
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vistakon (senofilcon a) contact lens, clear and visibility tinted with uv blocker. The device is indicated for use as follows: the vistakon (senofilcon a) soft contact lens (spherical) is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1. 00d or less of astigmatism. The vistakon (senofilcon a) multifocal soft contact lens is indicated for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0. 75d of astigmatism or less. The vistakon (senofilcon a) toric soft contact lens is indicated for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10. 00d of astigmatism or less. The vistakon (senofilcon a) multifocal-toric soft contact lens is indicated for the optical correction of distance and near in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10. 00d of astigmatism or less. The vistakon (senofilcon a) uv blocking soft contact lens help protect against transmission of harmful uv radiation to the cornea and into the eye. Eye care professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear the lenses may be cleaned and disinfected using a chemical disinfection system only. Vistakon (senofilcon a) contact lenses may be prescribed for daily wear and extended wear for up to 6 nights/7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing eye care professional.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
S026 S027 S028 S030 S031 S032 
S033 S034 S035 S036 S037 S039 
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