PMA P060022S014

Device
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S014
Product code
HQL
Decision date
2012-10-04
Generic name
intraocular lens
Approval order statement
NEW SUPPLIER FOR THE 2-HYDROXYL ETHYL METHACRYLATE (HEMA) MONOMER USED IN THE MANUFACTURE OF AKREOS IOLS.

Current openFDA PMA Record#

Device
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S014
Product code
HQL
Generic name
intraocular lens
Decision date
2012-10-04
Decision code
OK30
Date received
2012-08-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
NEW SUPPLIER FOR THE 2-HYDROXYL ETHYL METHACRYLATE (HEMA) MONOMER USED IN THE MANUFACTURE OF AKREOS IOLS.