PMA P060011S005

Device: 600C ASPHERIC INTRAOCULAR LENS
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S005
Product code: HQL
Decision date: 2015-05-01
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATIONTHE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.

Current openFDA PMA Record#

Device: 600C ASPHERIC INTRAOCULAR LENS
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S005
Product code: HQL
Generic name: intraocular lens
Decision date: 2015-05-01
Decision code: APPR
Date received: 2015-02-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING MODIFICATIONS OF THE C-FLEX ASPHERIC IOL MODEL 970C: 1) INCREASE OF OVERALL DIAMETER FROM 12.00 MM TO 12.50 MM; 2) INCREASE OF OPTIC SIZE FROM 5.75 MM TO 6.00 MM; AND 3) AN EXTENSION OF THE HIGH POWERED DIOPTRIC RANGE FROM +30.0D TO +34.0D. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 600C ASPHERIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATIONTHE LENS IS INTENDED TO BE PLACED IN THE CAPSULAR BAG.