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 ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY DR. FORT WORTH, TX 76134 |
PMA Number | P930014 |
Supplement Number | S084 |
Date Received | 08/07/2015 |
Decision Date | 09/29/2015 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO MODIFY THE ACRYSERT C DELIVERY SYSTEM BY REDUCING THE SIZE OF THE NOZZLE TIP, ADDING AN EXTERNAL NOZZLE TIP DEPTH GUARD, AND ADDING A PLUNGER SPRING AND PLUNGER LOCK, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ ASPHERIC INTRAOCULAR LENS WITH ULTRASERT PRELOADED DELIVERY SYSTEM. THE ACRYSOF IQ POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG. |
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