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 the acrysof toric posterior chamber intraocular lens models sa60t3, sa60t4 and sa60t5. The devices are indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
| Device | ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2005-03-18 |
| Decision Date | 2005-09-14 |
| Notice Date | 2005-09-23 |
| PMA | P930014 |
| Supplement | S015 |
| Product Code | HQL |
| Docket Number | 05M-0378 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway Dr. fort Worth, TX 76134 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |