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 envista one-piece hydrophobic acrylic toric intraocular lens (model mx60t). The device is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.
| Device | enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T) |
| Classification Name | Lens, Intraocular, Toric Optics |
| Generic Name | Lens, Intraocular, Toric Optics |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2017-10-30 |
| Decision Date | 2018-06-08 |
| Notice Date | 2018-06-19 |
| PMA | P910056 |
| Supplement | S027 |
| Product Code | MJP |
| Docket Number | 18M-2237 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910056 | Original Filing | |
| S049 | 2021-12-22 | 30-day Notice |
| S048 | 2021-09-22 | 30-day Notice |
| S047 | ||
| S046 | 2021-06-22 | 30-day Notice |
| S045 | ||
| S044 | 2020-12-04 | 30-day Notice |
| S043 | 2020-02-19 | Normal 180 Day Track |
| S042 | ||
| S041 | 2019-12-23 | 30-day Notice |
| S040 | 2019-12-20 | 30-day Notice |
| S039 | ||
| S038 | 2019-07-03 | 30-day Notice |
| S037 | ||
| S036 | 2019-04-03 | Normal 180 Day Track |
| S035 | 2018-10-16 | 30-day Notice |
| S034 | 2018-10-02 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | 2018-07-06 | 30-day Notice |
| S030 | 2018-06-11 | 30-day Notice |
| S029 | 2017-12-15 | 30-day Notice |
| S028 | 2017-11-08 | 30-day Notice |
| S027 | 2017-10-30 | Panel Track |
| S026 | 2017-10-02 | 30-day Notice |
| S025 | ||
| S024 | 2016-10-21 | Normal 180 Day Track |
| S023 | 2016-06-03 | 30-day Notice |
| S022 | 2016-05-03 | 30-day Notice |
| S021 | 2015-11-06 | 30-day Notice |
| S020 | 2015-03-30 | 30-day Notice |
| S019 | 2015-03-25 | 135 Review Track For 30-day Notice |
| S018 | 2014-08-11 | 30-day Notice |
| S017 | 2014-05-05 | Normal 180 Day Track |
| S016 | 2014-03-27 | 30-day Notice |
| S015 | 2013-12-05 | 30-day Notice |
| S014 | 2013-01-28 | 135 Review Track For 30-day Notice |
| S013 | 2012-09-07 | Real-time Process |
| S012 | 2012-08-06 | 30-day Notice |
| S011 | 2012-07-23 | Real-time Process |
| S010 | 2011-09-12 | Normal 180 Day Track |
| S009 | ||
| S008 | 2003-06-11 | Real-time Process |
| S007 | 1999-11-24 | Real-time Process |
| S006 | 1997-03-06 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 1992-06-16 | Normal 180 Day Track |
| S002 | 1992-04-28 | Normal 180 Day Track |
| S001 | 1991-11-06 | Normal 180 Day Track |