PMA P060022S030

Device
Akreos® Posterior Chamber Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S030
Product code
HQL
Decision date
2022-09-20
Generic name
intraocular lens
Approval order statement
Add the Bubble Leak Test to incoming inspection as an alternate test method.

Current openFDA PMA Record#

Device
Akreos® Posterior Chamber Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S030
Product code
HQL
Generic name
intraocular lens
Decision date
2022-09-20
Decision code
OK30
Date received
2022-08-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add the Bubble Leak Test to incoming inspection as an alternate test method.