PMA P930014S159

Device
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S159
Product code
HQL
Decision date
2025-12-12
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia

Current openFDA PMA Record#

Device
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S159
Product code
HQL
Generic name
intraocular lens
Decision date
2025-12-12
Decision code
OK30
Date received
2025-11-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval of a new cleanroom (Controlled Environment (CE)) for Intraocular lenses manufactured at Alcon Huntington, West Virginia