PMA P930014S122

Device
AcrySof Posterior Chamber Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S122
Product code
HQL
Decision date
2019-04-22
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Use the membrane filtration recovery method for bioburden testing of the AcrySof® Intraocular Lenses.

Current openFDA PMA Record#

Device
AcrySof Posterior Chamber Intraocular Lenses
Applicant
Alcon Laboratories, Inc.
PMA number
P930014
Supplement
S122
Product code
HQL
Generic name
intraocular lens
Decision date
2019-04-22
Decision code
OK30
Date received
2019-03-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use the membrane filtration recovery method for bioburden testing of the AcrySof® Intraocular Lenses.