PMA P060011S044

Device: Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S044
Product code: HQL
Decision date: 2026-01-20
Classification: Ophthalmic
Generic name: intraocular lens
Approval order statement: a change in the frequency of Bioburden monitoring of in-process RayOne injector and packaging components

Current openFDA PMA Record#

Device: Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S044
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-01-20
Decision code: OK30
Date received: 2025-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in the frequency of Bioburden monitoring of in-process RayOne injector and packaging components