AcrySof (R) Intraocular Lenses

FDA Premarket Approval P930014 S130

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

An alternate material for the iol optic mold subcomponent used in the manufacture of acrysof(r) intraocular lenses

DeviceAcrySof (R) Intraocular Lenses
Generic NameIntraocular Lens
ApplicantALCON LABORATORIES, INC.
Date Received2020-04-06
Decision Date2020-05-05
PMAP930014
SupplementS130
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES, INC. 6201 South Freeway Dr. fort Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P930014Original Filing
S130 2020-04-06 30-day Notice
S129 2020-03-30 30-day Notice
S128 2019-09-11 30-day Notice
S127 2019-08-30 30-day Notice
S126
S125 2019-07-22 30-day Notice
S124
S123 2019-07-05 30-day Notice
S122 2019-03-25 30-day Notice
S121 2019-03-25 30-day Notice
S120
S119 2019-03-01 30-day Notice
S118 2018-11-20 30-day Notice
S117 2018-11-07 30-day Notice
S116 2018-10-05 30-day Notice
S115 2018-09-12 30-day Notice
S114 2018-09-10 30-day Notice
S113 2018-09-07 30-day Notice
S112 2018-05-02 Real-time Process
S111 2018-03-16 30-day Notice
S110 2018-01-29 Real-time Process
S109 2017-12-21 30-day Notice
S108 2017-11-28 30-day Notice
S107 2017-11-21 30-day Notice
S106 2017-11-13 30-day Notice
S105 2017-09-08 30-day Notice
S104 2017-06-15 135 Review Track For 30-day Notice
S103 2017-06-06 Real-time Process
S102 2017-04-21 Real-time Process
S101 2017-04-06 30-day Notice
S100
S099 2016-12-02 Real-time Process
S098 2016-11-30 30-day Notice
S097 2016-11-16 Normal 180 Day Track
S096 2016-10-26 Real-time Process
S095 2016-08-03 30-day Notice
S094 2016-07-29 135 Review Track For 30-day Notice
S093 2016-07-21 30-day Notice
S092 2016-07-20 Real-time Process
S091 2016-05-13 Real-time Process
S090 2016-04-08 30-day Notice
S089 2016-03-09 30-day Notice
S088 2015-12-09 30-day Notice
S087 2015-12-07 30-day Notice
S086 2015-10-21 30-day Notice
S085 2015-09-08 Real-time Process
S084 2015-08-07 Real-time Process
S083 2015-07-27 30-day Notice
S082 2015-07-20 Normal 180 Day Track No User Fee
S081 2015-06-18 30-day Notice
S080 2015-05-22 Real-time Process
S079 2015-04-06 30-day Notice
S078 2015-02-12 30-day Notice
S077 2014-12-19 Normal 180 Day Track No User Fee
S076 2014-12-16 Real-time Process
S075 2014-09-26 30-day Notice
S074 2014-07-24 Normal 180 Day Track No User Fee
S073 2014-06-19 30-day Notice
S072 2013-12-19 30-day Notice
S071 2013-12-19 30-day Notice
S070 2013-12-11 30-day Notice
S069 2013-07-31 Normal 180 Day Track
S068 2013-04-22 30-day Notice
S067 2013-03-20 30-day Notice
S066 2012-12-26 Normal 180 Day Track No User Fee
S065 2012-12-20 30-day Notice
S064 2012-10-01 30-day Notice
S063 2012-07-20 30-day Notice
S062 2012-05-29 30-day Notice
S061 2012-03-12 30-day Notice
S060 2012-03-06 Real-time Process
S059 2012-02-13 30-day Notice
S058 2012-02-06 Normal 180 Day Track No User Fee
S057 2012-01-17 30-day Notice
S056 2011-09-02 30-day Notice
S055 2011-09-01 Real-time Process
S054 2011-08-29 30-day Notice
S053 2011-07-05 30-day Notice
S052 2011-07-01 30-day Notice
S051 2011-06-30 30-day Notice
S050 2011-06-24 30-day Notice
S049 2011-06-09 30-day Notice
S048 2011-06-02 Normal 180 Day Track No User Fee
S047 2011-02-10 30-day Notice
S046 2010-10-19 30-day Notice
S045 2010-08-31 Panel Track
S044 2010-08-25 30-day Notice
S043 2010-08-18 30-day Notice
S042 2010-08-10 30-day Notice
S041 2010-05-03 30-day Notice
S040 2010-05-03 30-day Notice
S039 2010-02-02 Real-time Process
S038 2010-01-19 30-day Notice
S037 2009-12-24 30-day Notice
S036 2009-10-19 30-day Notice
S035 2009-06-30 30-day Notice
S034 2009-06-18 135 Review Track For 30-day Notice
S033 2009-05-11 30-day Notice
S032 2009-05-11 30-day Notice
S031 2009-02-20 30-day Notice
S030 2009-01-06 30-day Notice
S029 2008-12-12 Real-time Process
S028 2008-09-23 30-day Notice
S027 2008-07-31 30-day Notice
S026 2008-07-28 30-day Notice
S025 2008-05-22 135 Review Track For 30-day Notice
S024 2008-04-21 Real-time Process
S023 2008-01-15 Real-time Process
S022 2007-10-31 30-day Notice
S021
S020 2007-04-10 135 Review Track For 30-day Notice
S019 2006-12-19 Normal 180 Day Track No User Fee
S018 2006-07-24 30-day Notice
S017 2006-03-02 Normal 180 Day Track
S016 2005-11-14 Real-time Process
S015 2005-03-18 Panel Track
S014 2004-04-16 Real-time Process
S013 2003-11-21 Real-time Process
S012 2003-08-05 Special (immediate Track)
S011 2003-07-25 Real-time Process
S010 2002-09-11 Normal 180 Day Track
S009 2001-12-26 Normal 180 Day Track
S008 2000-09-27 30-day Notice
S007
S006 1998-12-14 Normal 180 Day Track
S005 1997-06-23 Normal 180 Day Track
S004 1996-10-24 Normal 180 Day Track
S003 1996-08-08 Normal 180 Day Track
S002 1995-09-27 Normal 180 Day Track
S001 1995-01-31 Normal 180 Day Track

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