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.
 
DeviceACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS016
Date Received11/14/2005
Decision Date12/16/2005
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR IOL MODELS SN60T3, SN60T4 AND SN60T5. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF TORIC SINGLE-PIECE NATURAL IOL AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR VISUAL CORRECTION OF APHAKIA AND PRE-EXISTING CORNEAL ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA, WHO DESIRE IMPROVED SPECTACLE INDEPENDENCE FOR DISTANCE VISION.
-
-