Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)

FDA Premarket Approval P190018 S017

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

Modifications to the sampling plan for edge thickness

DeviceClareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2021-12-02
Decision Date2021-12-28
PMAP190018
SupplementS017
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Research, Ltd. 6201 South Freeway, Tc-467 forth Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P190018Original Filing
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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