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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 MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS046
Date Received10/17/2013
Decision Date04/28/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THE INTRAOCULAR LENS IS INTENDED TO BE PLACED IN THECAPSULAR BAG.
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