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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 One Piece Hydrophobic Acrylic Intraocular Lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS036
Date Received04/03/2019
Decision Date07/02/2019
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the enVista® One Piece Hydrophobic Acrylic IOL, Model MX60ET, which includes a modification to the intraocular lens (IOL) material formulation of the approved parent lens, enVista® Model MX60T.
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