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® multifocal 1-piece intraocular lens, models zkb00 and zlb00. This device is indicated for primary implantation for the visual correction of aphakia in adult patients with andwithout presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. Theintraocular lenses are intended to be placed in the capsular bag.
Device | TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL) |
Classification Name | Lens, Multifocal Intraocular |
Generic Name | Lens, Multifocal Intraocular |
Applicant | Johnson & Johnson Surgical Vision, Inc. |
Date Received | 2014-06-30 |
Decision Date | 2014-12-17 |
Notice Date | 2015-03-19 |
PMA | P980040 |
Supplement | S049 |
Product Code | MFK |
Docket Number | 14M-2375 |
Advisory Committee | Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/components/specifications/material |
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 |
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 |