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 | ACRYSOF IQ RESTOR IOLS +3.0 D |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P040020 |
Supplement Number | S012 |
Date Received | 07/01/2008 |
Decision Date | 12/22/2008 |
Product Code |
MFK |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00684138
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ACRYSOF IQ RESTOR INTRAOCULAR LENS +3.0 ADD POWER.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTORINTRAOCULAR LENS +3.0D (MODELS SN6AD1 AND MN6AD1) AND IS INDICATED FOR PRIMARYIMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS INADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE, AND DISTANCE VISION WITH INCREASED SPECTACLE INDEPENDENCE. THIS LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
|
|