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. |
|
Device | TECNIS TORIC 1-PEICE INTRAOCULAR LENS |
Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S039 |
Date Received | 04/09/2012 |
Decision Date | 04/15/2013 |
Product Code |
MJP |
Docket Number | 13M-0463 |
Notice Date | 04/24/2013 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
|
|