AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOLs

FDA Premarket Approval P040020 S095

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

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p040020/s049.

DeviceAcrySof IQ ReSTOR +3.0 D Multifocal Toric IOLs
Generic NameLens, Multifocal Intraocular
ApplicantAlcon Research, Ltd.
Date Received2020-07-31
Decision Date2020-08-28
PMAP040020
SupplementS095
Product CodeMFK 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
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
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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