Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP880081
Supplement NumberS032
Date Received05/30/2006
Decision Date07/20/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
-
-