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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.
 
DeviceENVISTA HYDROPHOBIC INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS019
Date Received03/25/2015
Decision Date11/19/2015
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE COMPONENT SUPPLIER FOR THE ACRYLIC SHEET USED TO MILL ENVISTA® HYDROPHOBIC INTRAOCULAR LENS BUTTONS (MODEL MX60). SPECIFICALLY, THE SHEET MANUFACTURING PROCESS IS TO ALTERNATIVELY TRANSFER TO THE BAUSCH AND LOMB FACILITY IN WILMINGTON, MASSACHUSETTS (WIL).
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