PMA P930014S114

Device
AcrySof Posterior Chamber Single Piece Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S114
Product code
HQL
Decision date
2018-10-04
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Introduce an alternate manufacturing tool to be used during the AcrySof monomer formulation process.

Current openFDA PMA Record#

Device
AcrySof Posterior Chamber Single Piece Intraocular Lens
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S114
Product code
HQL
Generic name
intraocular lens
Decision date
2018-10-04
Decision code
OK30
Date received
2018-09-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduce an alternate manufacturing tool to be used during the AcrySof monomer formulation process.