Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery

FDA Premarket Approval P190018 S015

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

A 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

DeviceClareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2021-11-23
Decision Date2021-12-21
PMAP190018
SupplementS015
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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