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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 Acrylic Intraocular Lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS051
Date Received01/17/2023
Decision Date08/21/2023
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 for the introduction of the UV + Duo material across the entire enVista® IOL portfolio along with the additions to the model number configurations, introduction of two additional IOL models (the enVista® ASPIRE monofocal [EA] and the enVista® ASPIRE toric [ETA]), and the inclusion of the option to have an electronic Instructions for Use (eIFU).
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