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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantJohnson & Johnson Vision Care, Inc.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE, FL 32256
PMA NumberP990085
Date Received12/20/1999
Decision Date02/16/2001
Withdrawal Date 02/14/2020
Product Code LPM 
Docket Number 01M-0149
Notice Date 03/26/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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