PMA P060011S002

Device: C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S002
Product code: HQL
Decision date: 2011-11-22
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 570C, AS WELL AS THE ADDITION OF A MODULATION TRANSFER FUNCTION (MTF) FIGURE TO THE PHYSICIANS LABELING COMPARING BOTH MODELS (I.E., 970C AND 570C).

Current openFDA PMA Record#

Device: C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C
Applicant: Rayner Intraocular Lenses , Ltd.
PMA number: P060011
Supplement: S002
Product code: HQL
Generic name: intraocular lens
Decision date: 2011-11-22
Decision code: APPR
Date received: 2011-09-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 570C, AS WELL AS THE ADDITION OF A MODULATION TRANSFER FUNCTION (MTF) FIGURE TO THE PHYSICIANS LABELING COMPARING BOTH MODELS (I.E., 970C AND 570C).