TECNIS® Multifocal Foldable Posterior Chamber IOL

FDA Premarket Approval P080010 S021

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

DeviceTECNIS® Multifocal Foldable Posterior Chamber IOL
Generic NameLens, Multifocal Intraocular
ApplicantJohnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-11-09
Decision Date2022-12-06
PMAP080010
SupplementS021
Product CodeMFK 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
irvine, CA 92618 PMA NumberP080010 Supplement NumberS021 Date Received11/09/2022 Decision Date12/06/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
adding An Alternative Supplier For The Lens Case Assembly (LCA)

Supplemental Filings

Supplement NumberDateSupplement Type
P080010Original Filing
S021 2022-11-09 30-day Notice
S020 2020-12-10 30-day Notice
S019
S018 2019-02-26 30-day Notice
S017 2018-12-21 30-day Notice
S016 2018-12-21 30-day Notice
S015 2018-04-11 30-day Notice
S014 2017-09-28 30-day Notice
S013 2016-06-01 30-day Notice
S012 2015-12-18 30-day Notice
S011 2015-06-26 30-day Notice
S010 2013-11-26 30-day Notice
S009 2013-05-24 30-day Notice
S008 2012-04-23 30-day Notice
S007 2012-01-30 30-day Notice
S006
S005 2010-04-01 30-day Notice
S004 2009-06-30 30-day Notice
S003 2009-06-09 30-day Notice
S002 2009-04-28 Normal 180 Day Track No User Fee
S001 2009-01-27 Normal 180 Day Track

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