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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 (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namelenefilcon a contact lens
Regulation Number886.5925
ApplicantJOHNSON & JOHNSON VISION CARE, INC.
PMA NumberP990085
Date Received12/20/1999
Decision Date02/16/2001
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 01M-0149
Notice Date 03/26/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
The vistakon spherical (lenefilcon a) contact lens is indicated for daily and extended wear for the correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes. The lens is indicated for daily wear in aphakic persons. The lens may be worn by persons who have astigmatism of 1. 00 diopter or less which does not interfere with visual acuity. The vistakon bifocal (lenefilcon a) contact lens is indicated for daily and extended wear for the correction of distance and near vision in presbyopic not-aphakic persons with non-diseased eyes. The lens is indicated for daily wear in aphakic persons. The lens may be worn by persons who have astigmatism of 1. 00 diopter or less which does not interfere with visual acuity. The vistakon toric (lenefilcon a) contact lens is indicated for daily and extended wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have 10. 00 diopters or less of astigmatism. The lens is indicated for daily wear in aphakic persons. The vistakon toric bifocal (lenefilcon a) contact lens is indicated for daily and extended wear for the correction of distance and near vision in presbyopic not-aphakic persons with non-diseased eyes that have astigmatism of 10. 00 diopters or less. The lens is indicated for daily wear in aphakic persons.
Approval Order Approval Order
Supplements: S001 
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