| 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 | ACRYSOF IQ RESTOR IOLS 3.0 AND 4.0 D ADD POWERS |
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| Generic Name | Lens, multifocal intraocular |
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| Regulation Number | 886.3600 |
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| Applicant | Alcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134 |
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| PMA Number | P040020 |
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| Supplement Number | S014 |
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| Date Received | 03/09/2009 |
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| Decision Date | 08/20/2009 |
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| Product Code |
MFK |
| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT00684138
|
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR CHANGES TO THE LABELING,REVISING THE DIRECTIONS FOR USE (DFU) AND PATIENT BROCHURE WITH UPDATED SIX-MONTHFOLLOW UP DATA FROM THE CLINICAL INVESTIGATION FOR THE LENSES. THE DEVICES, AS MODIFIEDWILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR INTRAOCULAR LENSES(IOLS) +3.0 D (MODELS: SN6AD1 AND MN6AD1) AND +4.0 D (MODELS: SN6AD3 ANDMN6AD3) ADD POWERS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTIONOF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUTPRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE. THE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG. |
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