PMA P060011S004

Device
C-FLEX ASPHERIC INTRAOCULAR LENS
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S004
Product code
HQL
Decision date
2012-07-17
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 INTRAOCULAR LENS MODEL 570C (POWER RANGE +8.0 TO + 17.5 D).

Current openFDA PMA Record#

Device
C-FLEX ASPHERIC INTRAOCULAR LENS
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S004
Product code
HQL
Generic name
intraocular lens
Decision date
2012-07-17
Decision code
APPR
Date received
2012-05-29
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 INTRAOCULAR LENS MODEL 570C (POWER RANGE +8.0 TO + 17.5 D).