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 | CRYSTALENS SE, MODEL AT-45 SE |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S004 |
Date Received | 07/05/2005 |
Decision Date | 09/08/2005 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA. THE CRYSTALENS SE (MODEL AT-45 SE) PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION WHICH ALLOWS FOR NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES. |
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