PMA P930014S109

Device
AcrySof Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S109
Product code
HQL
Decision date
2018-01-08
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Elimination of a test performed during set-up of the manufacturing of your Acrysof and AcrySof ReSTOR multi-piece intraocular lenses.

Current openFDA PMA Record#

Device
AcrySof Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S109
Product code
HQL
Generic name
intraocular lens
Decision date
2018-01-08
Decision code
OK30
Date received
2017-12-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Elimination of a test performed during set-up of the manufacturing of your Acrysof and AcrySof ReSTOR multi-piece intraocular lenses.