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Device | TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S027 |
Date Received | 03/27/2012 |
Decision Date | 05/20/2013 |
Product Code |
MJP |
Docket Number | 13M-0724 |
Notice Date | 06/18/2013 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01140477
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |