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PMA P930014S111

Device
AcrySof Posterior Chamber Single Piece Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S111
Product code
HQL
Decision date
2018-04-11
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Implementation of an automated dimensional inspection system as an alternate process for dimensional inspection of AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.

Current openFDA PMA Record#

Device
AcrySof Posterior Chamber Single Piece Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S111
Product code
HQL
Generic name
intraocular lens
Decision date
2018-04-11
Decision code
OK30
Date received
2018-03-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an automated dimensional inspection system as an alternate process for dimensional inspection of AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.