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. |
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Device | TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P880081 |
Supplement Number | S032 |
Date Received | 05/30/2006 |
Decision Date | 07/20/2006 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN HAPTIC MATERIAL, ADDITION OF THE OPTIEDGE AND OF A MODIFIED PROLATE ANTERIOR OPTIC SURFACE TO THE SI20NB LENS AND LABELING CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002) AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION OR PHACOELMULSIFICA-TION. THESE DEVICES ARE INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
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