- Device
- C-flex lntraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric, RayOne Sph
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S027
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2021-06-15
- Decision code
- OK30
- Date received
- 2021-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Option to use an alternative lathe plus polishing process for the manufacture of RayOne EMV intraocular lenses.