| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER |
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| Generic Name | Lenses, soft contact, extended wear |
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| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256 |
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| PMA Number | N18033 |
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| Supplement Number | S035 |
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| Date Received | 01/29/2001 |
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| Decision Date | 04/12/2001 |
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| Product Codes |
LPL LPM |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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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