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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 IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista
Generic Nameintraocular lens
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS054
Date Received05/01/2024
Decision Date07/29/2024
Product Codes HQL MJP 
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
Approval Order Statement  
approval for a new packaging configuration (i.e., lens shuttle and vial ) for the enVista and enVista Aspire monofocal (toric and non-toric) hydrophobic acrylic intraocular lenses (IOL)
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