PMA P060011S014

Device: Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S014
Product code: HQL
Decision date: 2018-11-14
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for manufacturing process improvements for all Rayner FDA-approved Intraocular Lenses (IOLs) and a new packaging configuration for your 6.0 mm Aspheric IOL, Model 600C, into a preloaded injector.

Current openFDA PMA Record#

Device: Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S014
Product code: HQL
Generic name: intraocular lens
Decision date: 2018-11-14
Decision code: APPR
Date received: 2018-04-02
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for manufacturing process improvements for all Rayner FDA-approved Intraocular Lenses (IOLs) and a new packaging configuration for your 6.0 mm Aspheric IOL, Model 600C, into a preloaded injector.