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 iq restor intraocular lens +3. 0 add power. The device, as modified, will be marketed under the trade name acrysof iq restorintraocular lens +3. 0d (models sn6ad1 and mn6ad1) and is indicated for primaryimplantation for the visual correction of aphakia secondary to removal of a cataractous lens inadult patients with and without presbyopia, who desire near, intermediate, and distance vision with increased spectacle independence. This lens is intended to be placed in the capsular bag.
| Device | ACRYSOF IQ RESTOR IOLS +3.0 D |
| Classification Name | Lens, Multifocal Intraocular |
| Generic Name | Lens, Multifocal Intraocular |
| Applicant | Alcon Research, Ltd. |
| Date Received | 2008-07-01 |
| Decision Date | 2008-12-22 |
| PMA | P040020 |
| Supplement | S012 |
| Product Code | MFK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |