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: iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: HOYA SURGICAL OPTICS, INC.; 14768 PIPELINE AVENUE; CHINO HILLS, CA 91709
• PMA Number: P080004
• Supplement Number: S043
• Date Received: 10/04/2021
• Decision Date: 12/28/2021
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Real-Time Process
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for nine (9) changes to the routine Ethylene Oxide (EO) sterilization process, including:1) The sterilization equipment used in your routine EO sterilization process;2) the implementation of a unified set of EO sterilization process parameters for your US marketed products;3) the lower control limit for EO gas used in your routine EO sterilization process;4) the method for monitoring EO gas concentration;5) the frequency of EO sterilant residuals testing; 6) the Process Challenge Device (PCD) used during routine EO sterilization cycles and validation activities;7) the number of PCDs used during routine EO sterilization cycles and validation activities;8) the approach used for validation/re-validation activities; and9) the re-validation cycle.