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 Toric 1-Piece Intraocular Lense (IOLs)
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Johnson & Johnson Surgical Vision, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P980040
• Supplement Number: S115
• Date Received: 04/17/2020
• Decision Date: 10/14/2020
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for labeling modification to reflect the findings of the Post-Approval Study (PAS) for Models ZCT450, ZCT525, and ZCT600.