PMA P930014S125

Device
AcrySoft Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S125
Product code
HQL
Decision date
2019-08-19
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Use of coating solutions prepared at the manufacturing facility in West Virginia in the manufacture of UltraSert and AcrySert nozzle components.

Current openFDA PMA Record#

Device
AcrySoft Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S125
Product code
HQL
Generic name
intraocular lens
Decision date
2019-08-19
Decision code
OK30
Date received
2019-07-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of coating solutions prepared at the manufacturing facility in West Virginia in the manufacture of UltraSert and AcrySert nozzle components.