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PMA P930014S129

Device
AcrySof Intraocular Lenses and Delivery System
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S129
Product code
HQL
Decision date
2020-04-23
Generic name
intraocular lens
Approval order statement
Modifications to enable the automation of the nozzle coating process at Alcon Laboratories in Ireland as part of the manufacturing process for the AcrySof® IQ Aspheric IOL with UltraSert® Preloaded Delivery System, Model AU00T0.

Current openFDA PMA Record#

Device
AcrySof Intraocular Lenses and Delivery System
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S129
Product code
HQL
Generic name
intraocular lens
Decision date
2020-04-23
Decision code
OK30
Date received
2020-03-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modifications to enable the automation of the nozzle coating process at Alcon Laboratories in Ireland as part of the manufacturing process for the AcrySof® IQ Aspheric IOL with UltraSert® Preloaded Delivery System, Model AU00T0.