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.
Approval for clear toric and restor iols to be manufactured with the clear acrysof material.
| Device | ACRYSOF ASPHERIC UV ABSORBING TORIC INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2016-12-02 |
| Decision Date | 2017-03-02 |
| PMA | P930014 |
| Supplement | S099 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |