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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.
 
DeviceTRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP030002
Supplement NumberS027
Date Received03/27/2012
Decision Date05/20/2013
Product Code MJP 
Docket Number 13M-0724
Notice Date 06/18/2013
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INTERMEDIATE AND DISTANCE VISION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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