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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.
 
DeviceEN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS010
Date Received09/12/2011
Decision Date05/30/2012
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT01230060
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MATERIAL CHANGE AND DESIGN MODIFICATIONS (3-PIECE TO 1-PIECE DESIGN AND ASPHERIC SURFACE) TO THE APPROVED BAUSCH & LOMB SILICONE LENS C31UB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS CRYSTALLINE LENS HAS BEEN REMOVED.
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