AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

FDA Premarket Approval P040020 S101

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

Replacement of obsolete components and a minor software upgrade for the optical inspection equipment used to measure acrysof panoptix and panoptix toric intraocular lenses

DeviceAcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses
Generic NameLens, Multifocal Intraocular
ApplicantAlcon Research, Ltd.
Date Received2021-09-21
Decision Date2021-10-01
PMAP040020
SupplementS101
Product CodeMFK 
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 fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P040020Original Filing
S101 2021-09-21 30-day Notice
S100
S099 2021-06-16 30-day Notice
S098 2021-03-26 30-day Notice
S097 2020-11-25 30-day Notice
S096 2020-09-10 30-day Notice
S095 2020-07-31 Normal 180 Day Track No User Fee
S094
S093
S092 2019-09-11 30-day Notice
S091 2019-07-05 30-day Notice
S090 2019-03-25 30-day Notice
S089 2019-03-25 30-day Notice
S088 2019-03-01 Real-time Process
S087 2019-01-31 Panel Track
S086 2018-11-20 30-day Notice
S085 2018-11-07 30-day Notice
S084 2018-10-05 30-day Notice
S083 2018-09-12 30-day Notice
S082 2018-09-10 30-day Notice
S081 2018-09-07 30-day Notice
S080 2018-07-19 30-day Notice
S079 2018-05-02 Real-time Process
S078 2018-03-16 30-day Notice
S077 2017-12-21 30-day Notice
S076 2017-11-28 30-day Notice
S075 2017-11-21 30-day Notice
S074 2017-11-13 30-day Notice
S073 2017-10-17 Real-time Process
S072 2017-09-08 30-day Notice
S071 2017-06-15 135 Review Track For 30-day Notice
S070 2017-06-06 Real-time Process
S069 2017-04-06 30-day Notice
S068 2017-01-23 Normal 180 Day Track No User Fee
S067 2016-12-23 Real-time Process
S066 2016-12-02 Real-time Process
S065 2016-11-30 30-day Notice
S064 2016-07-29 135 Review Track For 30-day Notice
S063 2016-04-08 30-day Notice
S062
S061 2016-03-09 30-day Notice
S060 2016-02-04 30-day Notice
S059 2015-12-09 30-day Notice
S058 2015-10-21 Real-time Process
S057
S056 2015-02-12 30-day Notice
S055 2014-07-23 30-day Notice
S054 2014-06-19 30-day Notice
S053 2013-12-19 30-day Notice
S052 2013-12-19 30-day Notice
S051 2013-11-18 30-day Notice
S050 2013-08-30 Panel Track
S049 2013-08-09 Panel Track
S048 2013-07-31 Normal 180 Day Track
S047 2013-04-22 30-day Notice
S046 2013-03-20 30-day Notice
S045 2012-12-26 Normal 180 Day Track No User Fee
S044 2012-12-20 30-day Notice
S043 2012-10-01 30-day Notice
S042 2012-05-25 30-day Notice
S041 2012-03-12 30-day Notice
S040 2012-02-13 30-day Notice
S039 2012-01-17 30-day Notice
S038 2011-09-06 30-day Notice
S037 2011-09-02 30-day Notice
S036 2011-09-01 Real-time Process
S035 2011-08-29 30-day Notice
S034 2011-07-05 30-day Notice
S033 2011-07-01 30-day Notice
S032 2011-06-24 30-day Notice
S031 2011-06-09 30-day Notice
S030 2011-02-10 30-day Notice
S029 2010-11-01 Normal 180 Day Track No User Fee
S028 2010-10-19 30-day Notice
S027 2010-08-25 30-day Notice
S026 2010-08-10 30-day Notice
S025 2010-05-03 30-day Notice
S024 2010-05-03 30-day Notice
S023 2010-01-19 30-day Notice
S022 2009-12-24 30-day Notice
S021 2009-10-19 30-day Notice
S020 2009-09-02 30-day Notice
S019 2009-06-30 30-day Notice
S018 2009-06-18 135 Review Track For 30-day Notice
S017 2009-05-11 30-day Notice
S016 2009-05-11 30-day Notice
S015 2009-04-02 Real-time Process
S014 2009-03-09 Normal 180 Day Track
S013 2009-02-20 30-day Notice
S012 2008-07-01 Normal 180 Day Track
S011 2008-06-30 30-day Notice
S010 2008-04-15 Normal 180 Day Track No User Fee
S009 2008-03-17 30-day Notice
S008 2008-01-15 Real-time Process
S007 2007-12-20 30-day Notice
S006 2007-10-31 30-day Notice
S005 2007-08-06 Real-time Process
S004 2007-04-10 135 Review Track For 30-day Notice
S003 2006-10-31 Real-time Process
S002 2006-07-24 30-day Notice
S001 2005-07-12 Real-time Process

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