PMA P060022S029

Device
Akreos® Posterior Chamber Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S029
Product code
HQL
Decision date
2022-01-19
Generic name
intraocular lens
Approval order statement
Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.

Current openFDA PMA Record#

Device
Akreos® Posterior Chamber Intraocular Lens (IOL)
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S029
Product code
HQL
Generic name
intraocular lens
Decision date
2022-01-19
Decision code
OK30
Date received
2021-12-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updating the raw material specification for one chemical used in the formulation of the polishing slurry for the intraocular lenses.