Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher

FDA Premarket Approval P190018 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceClareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher
Generic NameIntraocular Lens
ApplicantAlcon Laboratories, LLC6201 South Freewayfort Worth, TX 76134 PMA NumberP190018 Supplement NumberS019 Date Received04/06/2022 Decision Date05/03/2022 Product Codes MJP HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-06
Decision Date2022-05-03
PMAP190018
SupplementS019
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAlcon Laboratories, LLC
6201 South Freeway
fort Worth, TX 76134 PMA NumberP190018 Supplement NumberS019 Date Received04/06/2022 Decision Date05/03/2022 Product Codes MJP HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
transfer Of The Nozzle Coating Process During Manufacturing Of The AutonoMe Automated Pre-loaded Delivery System From Alcon Huntington, West Virginia To Alcon Laboratories, Ireland

Supplemental Filings

Supplement NumberDateSupplement Type
P190018Original Filing
S020 2022-04-22 30-day Notice
S019 2022-04-06 30-day Notice
S018
S017 2021-12-02 30-day Notice
S016 2021-11-30 30-day Notice
S015 2021-11-23 30-day Notice
S014 2021-11-05 30-day Notice
S013
S012
S011 2021-03-26 30-day Notice
S010 2021-02-22 Normal 180 Day Track No User Fee
S009 2020-12-14 Real-time Process
S008 2020-10-30 30-day Notice
S007 2020-10-16 30-day Notice
S006 2020-08-31 30-day Notice
S005
S004 2020-05-19 30-day Notice
S003
S002
S001

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