PMA P930014S160

Device
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S160
Product code
HQL
Decision date
2026-02-11
Classification
Ophthalmic
Generic name
intraocular lens
Approval order statement
adding Alcon Cork, Ireland as an alternate manufacturing site for the AcrySof Vivity Blue Light-Filtering (BLF) intraocular lens (IOL), model DFT015

Current openFDA PMA Record#

Device
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S160
Product code
HQL
Generic name
intraocular lens
Decision date
2026-02-11
Decision code
OK30
Date received
2026-01-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
adding Alcon Cork, Ireland as an alternate manufacturing site for the AcrySof Vivity Blue Light-Filtering (BLF) intraocular lens (IOL), model DFT015