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.
Elimination of a test performed during set-up of the manufacturing of your acrysof and acrysof restor multi-piece intraocular lenses.
| Device | AcrySof Intraocular Lenses |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2017-12-21 |
| Decision Date | 2018-01-08 |
| PMA | P930014 |
| Supplement | S109 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway Dr. fort Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930014 | Original 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 |