FDA.reportPublic FDA data

PMA P190018S015

Device
Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S015
Product code
HQL
Decision date
2021-12-21
Generic name
intraocular lens
Approval order statement
Change in the microbiological test method for determination of pre-sterilization bioburden, and a change in the organism used to determine the bioburden enumeration correction factor.

Current openFDA PMA Record#

Device
Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery
Applicant
Alcon Laboratories, LLC
PMA number
P190018
Supplement
S015
Product code
HQL
Generic name
intraocular lens
Decision date
2021-12-21
Decision code
OK30
Date received
2021-11-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the microbiological test method for determination of pre-sterilization bioburden, and a change in the organism used to determine the bioburden enumeration correction factor.