- Device
- C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S020
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-03-30
- Decision code
- OK30
- Date received
- 2020-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce the option of allowing software toindependently and automatically check the critical parameters of a cycle and provide a verdict of the sterilization cycle outcome.