PMA P060011S011

Device: C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S011
Product code: HQL
Decision date: 2017-05-18
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Introduction of a new method for the quantification of Aluminum Oxide residues resulting from the polishing process of intraocular lens manufacture.

Current openFDA PMA Record#

Device: C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S011
Product code: HQL
Generic name: intraocular lens
Decision date: 2017-05-18
Decision code: OK30
Date received: 2017-04-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Introduction of a new method for the quantification of Aluminum Oxide residues resulting from the polishing process of intraocular lens manufacture.