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: TECNIS Multi-focal 3-pc, ZMA00
• Generic Name: Lens, multifocal intraocular
• Regulation Number: 886.3600
• Applicant: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P080010
• Supplement Number: S030
• Date Received: 12/15/2025
• Decision Date: 01/12/2026
• Product Code: MFK
• 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  
the qualification of additional sterilization chambers, preconditioning and aeration rooms, and 2x (double) terminal sterilization approaches