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 changes to the directions for use (dfu) to specify that the envista mx60 lens is approved for use with the medicel accuject 2. 6 injector set, or other injector sets that specifically identify the envista mx60 lens in the cleared labeling.
| Device | ENVISTA INTRAOCULAR LENS (IOL) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2012-07-23 |
| Decision Date | 2012-09-04 |
| PMA | P910056 |
| Supplement | S011 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |
| 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 |