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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.
 
DeviceACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 centurion pkwy.
jacksonville, FL 32256
PMA NumberN18033
Supplement NumberS035
Date Received01/29/2001
Decision Date04/12/2001
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ETAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR WITH UV BLOCKER AND THE FOLLWOING LISTED COLOR ADDITIVES: IRON OXIDE BLACK, IRON OXIDE BROWN, IRON OXIDE RED, IRON OXIDE YELLOW, TITANIUM DIOXIDE, PHTHALOCYANINATO (2-) COPPER, PHTHALOCYANINE GREEN AND VAT ORANGE 1. THE DEVICE WILL BE MARKETED WITH THE FOLLOWING TRADE NAMES AND INDICATNIONS: THE ACUVUE (R) 2 COLOURS CONTACT LENSES ARE INDICATED FOR DAILY WEAR TO ENHANCE OR LATER THE APPARENT COLOR OF THE EYE AND/OR FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 1.00D OR LESS OF ASTIGMATISM. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC, APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES WHO MAY HAVE 0.75D OF ASTIGMATISM OR LESS. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED EYES THAT ARE HYPEROPIC OR MYOPIC AND MAY HAVE 10.00D OF ASTIGMATISM OR LESS. THE ACUVUE(R) 2 COLOURS (ETAFILCON A) SOFT (HYDROPHILIC) TORIC-BIFOCAL CONTACT LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF DISTANCE AND NEAR VISION IN PRESBYOPIC APHAKIC OR NON-APHAKIC PERSONS WITH NON-DISEASED WHO MAY HAVE 10.00D OR ASTIGMATISM OR LESS. ACUVUE(R) 2 COLOURS UV BLOCKING CONTACT LENSES HELP PROTECT AGAINST TRANSMISSINO OF HARMFUL UV RADIATINO TO THE CORNEA AND INTO THE EYE. THE ACUTVUE(R) 2 COLOURS CONTACT LENSES MAY BE PRESCRIBED FOR DAILY WEAR. EYE CARE PRACTITIONERS MAY PRESCRIBE THE LENSES EITHER FOR SINGLE-USE DISPOSABLE WEAR OR FREQUENT/PLANNED REPLACEMENT WEAR WITH CLEANING, DISINFECTION AND SCHEDULED REPLACEMENT (SEE "WEARING SCHEDULE".) WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR, THE LENSES MAY BE DISINFECTED USING A CHEMICAL DISINFECTIO
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