AcrySof Intraocular Lenses

Intraocular Lens

FDA Premarket Approval P930014 S109

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

Elimination of a test performed during set-up of the manufacturing of your acrysof and acrysof restor multi-piece intraocular lenses.

DeviceAcrySof Intraocular Lenses
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2017-12-21
Decision Date2018-01-08
PMAP930014
SupplementS109
Product CodeHQL
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 Dr. fort Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P930014Original Filing
S144 2022-11-22 30-day Notice
S143 2022-04-22 30-day Notice
S142 2022-03-01 30-day Notice
S141
S140 2021-11-23 30-day Notice
S139 2021-07-26 30-day Notice
S138
S137 2021-06-16 30-day Notice
S136 2021-03-26 Real-time Process
S135 2021-03-26 30-day Notice
S134 2020-11-25 30-day Notice
S133 2020-09-10 30-day Notice
S132
S131
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.