PMA P060011S018

Device: C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S018
Product code: HQL
Decision date: 2019-07-31
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Revision of acceptance limits for the environmental monitoring process, moving environmental sampling in-house, and changes to the routine purified water sampling/test schedule.

Current openFDA PMA Record#

Device: C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S018
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-07-31
Decision code: OK30
Date received: 2019-07-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Revision of acceptance limits for the environmental monitoring process, moving environmental sampling in-house, and changes to the routine purified water sampling/test schedule.