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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.
 
DeviceLI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910061
Supplement NumberS013
Date Received03/30/2006
Decision Date07/20/2006
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING CHANGES FOR THE ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVANCED OPTICS VIOLET-SHIELD MODEL LI61AOV INTRAOCULAR LENS AND IS INDICATED TO BE USED FOR PRIMARY IMPLANTATION FOR THE CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION METHODS. THE LENS IS INTENDED FOR PLACEMENT IN THE CILIARY SULCUS OR CAPSULAR BAG.
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