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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 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.
 
DeviceACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER
Generic NameLenses, soft contact, extended wear
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
7500 CENTURION PKWY.
JACKSONVILLE, FL 32256
PMA NumberN18033
Supplement NumberS037
Date Received02/19/2002
Decision Date03/18/2002
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES FOR THE DEVICE. THE CHANGES WILL ADD ADDITIONAL STATEMENTS TO THE "PRECAUTIONS" SECTION OF THE PACKAGE INSERT TO ALERT BOTH DOCTORS AND PATIENTS ABOUT VISUAL SYMPTOMS AND/OR PERIPHERAL AWARENESS THAT PATIENTS MIGHT EXPERIENCE DUE TO A REDUCTION IN THE VISIBLE LIGHT TRANSMISSION. THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PACKAGE INSERT: "DUE TO REDUCTION IN LIGHT TRANSMITTANCE WITH COSMETICALLY TINTED LENSES, SOME PATIENTS MAY EXPERIENCE VISUAL SYMPTOMS WHILE WEARING ACUVUE 2 COLOURS BRAND. IN ADDITION, SOME PATIENTS MAY EXPERIENCE PERIPHERAL AWARENESS DUE TO THE OPAQUE IRIS PATTERN." THE FOLLOWING ADDITIONAL PRECAUTION STATEMENT WILL BE ADDED TO THE PATIENT INSTRUCTION GUIDES: "WHEN WEARING LENSES THAT ALTER YOUR EYE COLOR, YOU MAY NOTICE TEMPORARY DIFFERENCES IN YOUR VISION DUE TO A CHANGE IN THE AMOUNT OF LIGHT THAT ENTERS YOUR EYES. IF THESE DIFFERENCES IN VISION PERSIST WHEN WEARING ACUVUE 2 COLOURS BRAND, IT IS IMPORTANT THAT YOU CONSULT YOUR EYE CARE PROFESSIONAL."
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