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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.
 
DeviceACRYSOF NATURAL SINGLE PIECE INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS012
Date Received08/05/2003
Decision Date09/02/2003
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MODIFY THE PACKAGE INSERT TO CREATE A NEW WARNING BY MOVING AND STRENGTHENING EXISTING TEXT WITHIN THE APPROVED INSERT TO READ AS FOLLOWS: "THE CLINICAL STUDY OF THE ACRYSOF NATURAL SINGLE-PIECE LENS (REFERENCED IN TABLES 2 THROUGH 5) WAS CONDUCTED WITH THE LENS INTENDED FOR IMPLANTATION IN THE CAPSULAR BAG ONLY. THERE IS NO CLINICAL DATA TO DEMONSTRATE ITS SAFETY AND EFFECTIVENESS FOR PLACEMENT IN THE CILIARY SULCUS."
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