This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the acrysof restor apodized diffractive optic posterior chamber intraocular lenses (iols), models ma60d3 and sa60d3. This device is 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. The lens is intended to be placed 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 | 2004-04-19 |
| Decision Date | 2005-03-21 |
| Notice Date | 2005-04-12 |
| PMA | P040020 |
| Supplement | S |
| Product Code | MFK |
| Docket Number | 05M-0117 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Research, Ltd. 6201 South Freeway fort Worth, TX 76134-2099 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |