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.
| Device | TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS155 Date Received11/18/2022 Decision Date12/12/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-18 |
| Decision Date | 2022-12-12 |
| PMA | P980040 |
| Supplement | S155 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive suite 200 irvine, CA 92618 PMA NumberP980040 Supplement NumberS155 Date Received11/18/2022 Decision Date12/12/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement adding An Alternate Manufacturing And Sterilization Site At AMO Groningen B.V., Van Swietenlaan 5, Groningen, The Netherlands 9728NX For TECNISEyhance IOL With TECNIS Simplicity Delivery System, Model DIB00, And TECNIS Eyhance Toric II IOLs With TECNIS Simplicity Delivery System, Models DIU150-600 |
| 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 |