FDA.reportPublic FDA data

PMA P840060S043

Device
Single-Piece Posterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P840060
Supplement
S043
Product code
HQL
Decision date
2016-08-11
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
Single-Piece Posterior Chamber IOL
Applicant
Alcon Laboratories
PMA number
P840060
Supplement
S043
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.