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 revisions to the labeling for the tecnis one-piece intraocular lens, model zcb00 as follows: 1) modifications to the device description section to include an additional description of wavefront-designed aspheric optic, squared posterior optic edge, frosted optic edge, an optical image quality graph for the aspheric optic; 2) modifications to the adverse events sand the clinical trial sections to reflect data from the one-year clinical study results; and 3) other administrative changes such as the rewording of the last sentence on page 1, adding trademarks to the detailed device description section and revision the numbering of the figures.
| Device | TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2008-03-21 |
| Decision Date | 2008-05-27 |
| PMA | P980040 |
| Supplement | S023 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day 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 |
| 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 |