- Device
- iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S043
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-12-28
- Decision code
- APPR
- Date received
- 2021-10-04
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.