PMA P060022

Device
Akreos Posterior Chamber Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S030
Product code
HQL
Decision date
2025-09-30
Generic name
intraocular lens
Approval order statement
adding a second component supplier for a component of the primary packaging for the non-preloaded Akreos family of intraocular lenses (IOLs)

Current openFDA PMA Record#

Device
Akreos Posterior Chamber Intraocular Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P060022
Supplement
S037
Product code
HQL
Generic name
intraocular lens
Decision date
2025-09-30
Decision code
OK30
Date received
2025-09-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
adding a second component supplier for a component of the primary packaging for the non-preloaded Akreos family of intraocular lenses (IOLs)