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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 TORIC 1-PEICE INTRAOCULAR LENS
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS039
Date Received04/09/2012
Decision Date04/15/2013
Product Code MJP 
Docket Number 13M-0463
Notice Date 04/24/2013
Advisory Committee Ophthalmic
Clinical TrialsNCT01098812
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE TECNJS® TORIC 1-PIECE IOL, MODELS ZCT150, ZCT225, ZCT300 AND ZCT400, AND THE TECNIS® TORIC CALCULATOR SYSTEM. THIS DEVICE IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM OF ONE DIOPTER OR GREATER IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE IMPROVED UNCORRECTED DISTANCE VISION, REDUCTION IN RESIDUAL REFRACTIVE CYLINDER AND INCREASEDSPECTACLE INDEPENDENCE FOR DISTANCE VISION. THE DEVICE IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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