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 acrysof restor natural intraocular lens (iol) models sn60d3 and mn60d3 (level a modification: addition of chromophore). The device, as modified, will be marketed under the trade name acrysof restor natural iol and is indicated for primary implantation for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.
| Device | ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3 |
| Classification Name | Lens, Multifocal Intraocular |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2005-07-12 |
| Decision Date | 2005-07-29 |
| PMA | P040020 |
| Supplement | S001 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040020 | Original Filing | |
| S104 | 2022-11-22 | 30-day Notice |
| S103 | 2022-04-22 | 30-day Notice |
| S102 | 2022-03-01 | 30-day Notice |
| S101 | 2021-09-21 | 30-day Notice |
| S100 | ||
| S099 | 2021-06-16 | 30-day Notice |
| S098 | 2021-03-26 | 30-day Notice |
| S097 | 2020-11-25 | 30-day Notice |
| S096 | 2020-09-10 | 30-day Notice |
| S095 | 2020-07-31 | Normal 180 Day Track No User Fee |
| S094 | ||
| S093 | ||
| S092 | 2019-09-11 | 30-day Notice |
| S091 | 2019-07-05 | 30-day Notice |
| S090 | 2019-03-25 | 30-day Notice |
| S089 | 2019-03-25 | 30-day Notice |
| S088 | 2019-03-01 | Real-time Process |
| S087 | 2019-01-31 | Panel Track |
| S086 | 2018-11-20 | 30-day Notice |
| S085 | 2018-11-07 | 30-day Notice |
| S084 | 2018-10-05 | 30-day Notice |
| S083 | 2018-09-12 | 30-day Notice |
| S082 | 2018-09-10 | 30-day Notice |
| S081 | 2018-09-07 | 30-day Notice |
| S080 | 2018-07-19 | 30-day Notice |
| S079 | 2018-05-02 | Real-time Process |
| S078 | 2018-03-16 | 30-day Notice |
| S077 | 2017-12-21 | 30-day Notice |
| S076 | 2017-11-28 | 30-day Notice |
| S075 | 2017-11-21 | 30-day Notice |
| S074 | 2017-11-13 | 30-day Notice |
| S073 | 2017-10-17 | Real-time Process |
| S072 | 2017-09-08 | 30-day Notice |
| S071 | 2017-06-15 | 135 Review Track For 30-day Notice |
| S070 | 2017-06-06 | Real-time Process |
| S069 | 2017-04-06 | 30-day Notice |
| S068 | 2017-01-23 | Normal 180 Day Track No User Fee |
| S067 | 2016-12-23 | Real-time Process |
| S066 | 2016-12-02 | Real-time Process |
| S065 | 2016-11-30 | 30-day Notice |
| S064 | 2016-07-29 | 135 Review Track For 30-day Notice |
| S063 | 2016-04-08 | 30-day Notice |
| S062 | ||
| S061 | 2016-03-09 | 30-day Notice |
| S060 | 2016-02-04 | 30-day Notice |
| S059 | 2015-12-09 | 30-day Notice |
| S058 | 2015-10-21 | Real-time Process |
| S057 | ||
| S056 | 2015-02-12 | 30-day Notice |
| S055 | 2014-07-23 | 30-day Notice |
| S054 | 2014-06-19 | 30-day Notice |
| S053 | 2013-12-19 | 30-day Notice |
| S052 | 2013-12-19 | 30-day Notice |
| S051 | 2013-11-18 | 30-day Notice |
| S050 | 2013-08-30 | Panel Track |
| S049 | 2013-08-09 | Panel Track |
| S048 | 2013-07-31 | Normal 180 Day Track |
| S047 | 2013-04-22 | 30-day Notice |
| S046 | 2013-03-20 | 30-day Notice |
| S045 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S044 | 2012-12-20 | 30-day Notice |
| S043 | 2012-10-01 | 30-day Notice |
| S042 | 2012-05-25 | 30-day Notice |
| S041 | 2012-03-12 | 30-day Notice |
| S040 | 2012-02-13 | 30-day Notice |
| S039 | 2012-01-17 | 30-day Notice |
| S038 | 2011-09-06 | 30-day Notice |
| S037 | 2011-09-02 | 30-day Notice |
| S036 | 2011-09-01 | Real-time Process |
| S035 | 2011-08-29 | 30-day Notice |
| S034 | 2011-07-05 | 30-day Notice |
| S033 | 2011-07-01 | 30-day Notice |
| S032 | 2011-06-24 | 30-day Notice |
| S031 | 2011-06-09 | 30-day Notice |
| S030 | 2011-02-10 | 30-day Notice |
| S029 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S028 | 2010-10-19 | 30-day Notice |
| S027 | 2010-08-25 | 30-day Notice |
| S026 | 2010-08-10 | 30-day Notice |
| S025 | 2010-05-03 | 30-day Notice |
| S024 | 2010-05-03 | 30-day Notice |
| S023 | 2010-01-19 | 30-day Notice |
| S022 | 2009-12-24 | 30-day Notice |
| S021 | 2009-10-19 | 30-day Notice |
| S020 | 2009-09-02 | 30-day Notice |
| S019 | 2009-06-30 | 30-day Notice |
| S018 | 2009-06-18 | 135 Review Track For 30-day Notice |
| S017 | 2009-05-11 | 30-day Notice |
| S016 | 2009-05-11 | 30-day Notice |
| S015 | 2009-04-02 | Real-time Process |
| S014 | 2009-03-09 | Normal 180 Day Track |
| S013 | 2009-02-20 | 30-day Notice |
| S012 | 2008-07-01 | Normal 180 Day Track |
| S011 | 2008-06-30 | 30-day Notice |
| S010 | 2008-04-15 | Normal 180 Day Track No User Fee |
| S009 | 2008-03-17 | 30-day Notice |
| S008 | 2008-01-15 | Real-time Process |
| S007 | 2007-12-20 | 30-day Notice |
| S006 | 2007-10-31 | 30-day Notice |
| S005 | 2007-08-06 | Real-time Process |
| S004 | 2007-04-10 | 135 Review Track For 30-day Notice |
| S003 | 2006-10-31 | Real-time Process |
| S002 | 2006-07-24 | 30-day Notice |
| S001 | 2005-07-12 | Real-time Process |