- Device
- C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S024
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2020-06-24
- Decision code
- OK30
- Date received
- 2020-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative supplier of 0.9% w/v sodium chloride, new tubing for controlled dosing of saline, and a new desktop autoclave for sterilization of new tubing.