Clareon Intraocular Lenses with the AutonoMe Delivery System

FDA Premarket Approval P190018 S007

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

Adding an alternate supplier for the hydrophilic monomer used for the manufacturing of the clareon™ intraocular lens (iol) in the alcon ireland manufacturing site

DeviceClareon Intraocular Lenses with the AutonoMe Delivery System
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2020-10-16
Decision Date2020-11-12
PMAP190018
SupplementS007
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
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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