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 expansion of the dioptric range of the referenced models from 10. 0d to 30. 0d to 6. 0d to 30. 0d. The device models, as modified, will be marketed under the trade name acrysof restor apodized diffractive optic posterior chamber intraocular lens (iol), models sa60d3, sn60d3, ma60d3 and mn60d3, and are indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. These lenses are intended for placement in the capsular bag.
| Device | ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL |
| Classification Name | Lens, Multifocal Intraocular |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2007-08-06 |
| Decision Date | 2007-10-24 |
| PMA | P040020 |
| Supplement | S005 |
| 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 |