| 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 +2.5 D MULTIFOCAL INTRAOCULAR LENS |
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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 South Freeway
Fort Worth, TX 76134-2099 |
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| PMA Number | P040020 |
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| Supplement Number | S050 |
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| Date Received | 08/30/2013 |
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| Decision Date | 04/13/2015 |
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| Product Code |
MFK |
| Docket Number | 15M-1325 |
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| Notice Date | 04/29/2015 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT01510717
|
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| Supplement Type | Panel Track |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE ACRYSOF® IQ RESTOR® +2.5 D MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL SV25T0. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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