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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.
 
DeviceTECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS068
Date Received04/18/2016
Decision Date05/13/2016
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternate molding supplier for the lower and upper body components used in all TECNIS iTec Preloaded Delivery System lens models manufactured at the AMO Puerto Rico and AMO Groningen BV sites.
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