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PMA P810032S066

Device
Multi-Piece Posterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P810032
Supplement
S066
Product code
HQL
Decision date
2016-08-11
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.

Current openFDA PMA Record#

Device
Multi-Piece Posterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P810032
Supplement
S066
Product code
HQL
Generic name
intraocular lens
Decision date
2016-08-11
Decision code
OK30
Date received
2016-08-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.