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: Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Hoya Surgical Optics, Inc.; 14768 Pipeline Ave.; Chino Hills, CA 91709
• PMA Number: P080004
• Supplement Number: S018
• Date Received: 10/02/2017
• Decision Date: 10/13/2017
• 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  
Change in sample size for quality checks.