PMA P060011S043
- Device
- C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S043
- Product code
- HQL
- Decision date
- 2025-12-23
- Classification
- Ophthalmic
- Generic name
- intraocular lens
- Approval order statement
- a new release-and-wash-bath process to be used during the lens profiling and milling operations
Current openFDA PMA Record#
- Device
- C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S043
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-12-23
- Decision code
- OK30
- Date received
- 2025-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new release-and-wash-bath process to be used during the lens profiling and milling operations