PMA P060011S010

Device: C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL)
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S010
Product code: HQL
Decision date: 2016-08-19
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Change the final stage of the tumble polish process for C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses.

Current openFDA PMA Record#

Device: C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL)
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S010
Product code: HQL
Generic name: intraocular lens
Decision date: 2016-08-19
Decision code: OK30
Date received: 2016-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the final stage of the tumble polish process for C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses.