- Device
- C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S016
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2019-03-28
- Decision code
- OK30
- Date received
- 2019-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional alternate testing laboratory for endotoxin and bioburden testing for the Rayner intraocular lenses.