- Device
- iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
- Applicant
- Hoya Surgical Optics, Inc.
- PMA number
- P080004
- Supplement
- S040
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-05-07
- Decision code
- OK30
- Date received
- 2021-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the ethylene oxide ink indicator on individual sterilization pouches of fully preloaded intraocular lens devices, and replacement with an ethylene oxide indicator sticker that will be attached to the sterilization tray during batch sterilization.