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 tecnis symfony extended range of vision intraocular lens. The tecnis® symfony extended range of vision iol, model zxr00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal iol, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model zxr00 iol is intended for capsular bag placement only. The tecnis® symfony toric extended range of vision iols, models zxt150, zxt225, zxt300, and zxt375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal iol, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The model series zxt iols are intended for capsular bag placement only.
| Device | TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2016-01-19 |
| Decision Date | 2016-07-15 |
| Notice Date | 2016-07-25 |
| PMA | P980040 |
| Supplement | S065 |
| Product Code | HQL |
| Docket Number | 16M-2184 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| 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 |
|---|---|---|
| P980040 | Original Filing | |
| S155 | 2022-11-18 | 30-day Notice |
| S154 | 2022-11-17 | 30-day Notice |
| S153 | ||
| S152 | 2022-10-25 | 30-day Notice |
| S151 | 2022-09-28 | 30-day Notice |
| S150 | 2022-09-12 | 30-day Notice |
| S149 | 2022-07-01 | 30-day Notice |
| S148 | 2022-06-24 | 30-day Notice |
| S147 | 2022-04-28 | 30-day Notice |
| S146 | 2022-03-02 | 30-day Notice |
| S145 | 2022-01-24 | 30-day Notice |
| S144 | 2021-12-20 | Normal 180 Day Track |
| S143 | ||
| S142 | 2021-10-01 | Real-time Process |
| S141 | 2021-07-06 | 30-day Notice |
| S140 | ||
| S139 | ||
| S138 | 2021-06-04 | 30-day Notice |
| S137 | 2021-06-03 | 30-day Notice |
| S136 | 2021-05-21 | Normal 180 Day Track No User Fee |
| S135 | 2021-05-10 | 30-day Notice |
| S134 | 2021-04-06 | 30-day Notice |
| S133 | ||
| S132 | 2021-02-25 | 30-day Notice |
| S131 | 2021-02-09 | 30-day Notice |
| S130 | 2021-01-27 | 30-day Notice |
| S129 | 2021-01-05 | 30-day Notice |
| S128 | 2020-12-16 | 30-day Notice |
| S127 | 2020-12-10 | 30-day Notice |
| S126 | 2020-10-16 | 30-day Notice |
| S125 | ||
| S124 | ||
| S123 | 2020-10-01 | 30-day Notice |
| S122 | 2020-09-03 | 30-day Notice |
| S121 | 2020-08-25 | 30-day Notice |
| S120 | ||
| S119 | 2020-07-06 | 30-day Notice |
| S118 | ||
| S117 | ||
| S116 | ||
| S115 | ||
| S114 | ||
| S113 | ||
| S112 | 2020-02-28 | Real-time Process |
| S111 | ||
| S110 | 2019-11-08 | 30-day Notice |
| S109 | ||
| S108 | 2019-09-16 | 30-day Notice |
| S107 | ||
| S106 | 2019-08-19 | 30-day Notice |
| S105 | 2019-07-16 | 30-day Notice |
| S104 | 2019-06-19 | 30-day Notice |
| S103 | ||
| S102 | 2019-03-04 | 30-day Notice |
| S101 | 2019-02-26 | 30-day Notice |
| S100 | ||
| S099 | ||
| S098 | ||
| S097 | 2018-12-21 | 30-day Notice |
| S096 | 2018-12-21 | 30-day Notice |
| S095 | ||
| S094 | 2018-11-20 | 30-day Notice |
| S093 | 2018-09-19 | Normal 180 Day Track No User Fee |
| S092 | 2018-06-27 | 30-day Notice |
| S091 | 2018-05-15 | 30-day Notice |
| S090 | 2018-05-15 | 30-day Notice |
| S089 | 2018-05-04 | 135 Review Track For 30-day Notice |
| S088 | 2018-04-11 | 30-day Notice |
| S087 | 2018-03-19 | 30-day Notice |
| S086 | 2018-02-16 | Normal 180 Day Track No User Fee |
| S085 | 2017-11-20 | 30-day Notice |
| S084 | 2017-09-28 | 30-day Notice |
| S083 | 2017-08-28 | 30-day Notice |
| S082 | 2017-05-12 | 30-day Notice |
| S081 | 2017-04-25 | 30-day Notice |
| S080 | 2017-04-10 | Normal 180 Day Track No User Fee |
| S079 | 2017-02-23 | 30-day Notice |
| S078 | 2017-02-22 | 30-day Notice |
| S077 | 2017-01-05 | Normal 180 Day Track No User Fee |
| S076 | 2016-11-14 | 30-day Notice |
| S075 | 2016-11-02 | 30-day Notice |
| S074 | 2016-09-09 | 30-day Notice |
| S073 | 2016-08-22 | 30-day Notice |
| S072 | 2016-08-15 | Normal 180 Day Track No User Fee |
| S071 | 2016-06-02 | 30-day Notice |
| S070 | 2016-06-01 | 30-day Notice |
| S069 | 2016-05-18 | 30-day Notice |
| S068 | 2016-04-18 | 30-day Notice |
| S067 | 2016-03-21 | Normal 180 Day Track No User Fee |
| S066 | 2016-01-28 | Normal 180 Day Track |
| S065 | 2016-01-19 | Panel Track |
| S064 | 2015-12-18 | 30-day Notice |
| S063 | 2015-11-17 | 30-day Notice |
| S062 | 2015-04-02 | Normal 180 Day Track No User Fee |
| S061 | 2015-04-01 | 30-day Notice |
| S060 | 2015-03-23 | 30-day Notice |
| S059 | 2015-02-20 | Normal 180 Day Track |
| S058 | 2015-02-02 | Normal 180 Day Track |
| S057 | 2015-01-29 | Real-time Process |
| S056 | 2014-12-24 | Normal 180 Day Track |
| S055 | 2014-12-03 | 30-day Notice |
| S054 | 2014-11-18 | 30-day Notice |
| S053 | 2014-10-20 | 30-day Notice |
| S052 | 2014-10-20 | 30-day Notice |
| S051 | 2014-10-16 | 30-day Notice |
| S050 | 2014-09-24 | 30-day Notice |
| S049 | 2014-06-30 | Panel Track |
| S048 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S047 | 2013-11-26 | 30-day Notice |
| S046 | 2013-10-17 | Normal 180 Day Track |
| S045 | 2013-05-24 | 30-day Notice |
| S044 | 2013-05-15 | Normal 180 Day Track No User Fee |
| S043 | 2013-05-15 | Normal 180 Day Track No User Fee |
| S042 | 2013-02-12 | 30-day Notice |
| S041 | 2012-09-04 | Normal 180 Day Track |
| S040 | 2012-04-23 | 30-day Notice |
| S039 | 2012-04-09 | Panel Track |
| S038 | 2012-01-30 | 30-day Notice |
| S037 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S036 | ||
| S035 | 2010-10-18 | Normal 180 Day Track |
| S034 | 2010-06-10 | 30-day Notice |
| S033 | 2010-04-22 | 30-day Notice |
| S032 | 2010-02-18 | 30-day Notice |
| S031 | ||
| S030 | 2009-07-30 | 135 Review Track For 30-day Notice |
| S029 | 2009-07-09 | Normal 180 Day Track |
| S028 | 2009-06-30 | 30-day Notice |
| S027 | 2009-06-09 | 30-day Notice |
| S026 | 2008-11-24 | 30-day Notice |
| S025 | 2008-08-29 | 30-day Notice |
| S024 | 2008-06-02 | 30-day Notice |
| S023 | 2008-03-21 | Normal 180 Day Track |
| S022 | 2007-12-21 | Normal 180 Day Track No User Fee |
| S021 | 2007-12-17 | 135 Review Track For 30-day Notice |
| S020 | 2007-12-14 | 30-day Notice |
| S019 | 2007-10-02 | 30-day Notice |
| S018 | 2007-09-24 | 30-day Notice |
| S017 | 2007-08-09 | 30-day Notice |
| S016 | 2007-06-13 | 30-day Notice |
| S015 | 2007-05-18 | Normal 180 Day Track |
| S014 | 2007-03-28 | 30-day Notice |
| S013 | 2007-03-27 | 30-day Notice |
| S012 | 2007-02-20 | 30-day Notice |
| S011 | 2007-02-20 | 30-day Notice |
| S010 | 2006-12-18 | 30-day Notice |
| S009 | 2006-12-18 | 30-day Notice |
| S008 | 2006-09-13 | 30-day Notice |
| S007 | 2005-09-30 | Normal 180 Day Track |
| S006 | 2005-01-03 | Real-time Process |
| S005 | 2003-10-31 | Real-time Process |
| S004 | ||
| S003 | 2001-11-19 | Normal 180 Day Track |
| S002 | 2001-04-30 | Normal 180 Day Track |
| S001 | 2001-03-08 | Normal 180 Day Track |