PMA P930014S135

Device
AcrySof Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S135
Product code
HQL
Decision date
2021-04-22
Generic name
intraocular lens
Approval order statement
Add an alternate supplier for a raw material (i.e. initiator) used in the manufacturing process.

Current openFDA PMA Record#

Device
AcrySof Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S135
Product code
HQL
Generic name
intraocular lens
Decision date
2021-04-22
Decision code
OK30
Date received
2021-03-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternate supplier for a raw material (i.e. initiator) used in the manufacturing process.