Premarket Approval (PMA)

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.

• Device: enVista® Hydrophobic Acrylic Intraocular Lens
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Bausch & Lomb, Inc.; 50 Technology Dr.; Irvine, CA 92618
• PMA Number: P910056
• Supplement Number: S064
• Date Received: 09/02/2026
• Decision Date: 09/30/2026
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
adding a new ISO Class 7 manufacturing cleanroom at the Clearwater Florida facility