PMA P930014S139

Device
AcrySof® Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S139
Product code
HQL
Decision date
2021-08-23
Generic name
intraocular lens
Approval order statement
Implement the use of a new Blister Sealer System for the packaging of the AcrySert® and UltraSert® Lens Delivery Systems.

Current openFDA PMA Record#

Device
AcrySof® Posterior Chamber Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S139
Product code
HQL
Generic name
intraocular lens
Decision date
2021-08-23
Decision code
OK30
Date received
2021-07-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement the use of a new Blister Sealer System for the packaging of the AcrySert® and UltraSert® Lens Delivery Systems.