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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS001
Date Received02/19/2013
Decision Date05/28/2013
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
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