PMA P060022S016

Device
AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S016
Product code
HQL
Decision date
2013-07-01
Generic name
intraocular lens
Approval order statement
APPROVAL FOR A LABELING CHANGE TO INCLUDE THE ADDITION OF A NEW INTRAOCULAR LENS (IOL) INSERTER, INJ100, IN THE DIRECTIONS FOR USE.

Current openFDA PMA Record#

Device
AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S016
Product code
HQL
Generic name
intraocular lens
Decision date
2013-07-01
Decision code
APPR
Date received
2013-04-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A LABELING CHANGE TO INCLUDE THE ADDITION OF A NEW INTRAOCULAR LENS (IOL) INSERTER, INJ100, IN THE DIRECTIONS FOR USE.