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 a material change and design modifications (3-piece to 1-piece design and aspheric surface) to the approved bausch & lomb silicone lens c31ub. The device, as modified, will be marketed under the trade name envista one-piece hydrophobic acrylic intraocular lens, model mx60 and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous crystalline lens has been removed.
| Device | EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2011-09-12 |
| Decision Date | 2012-05-30 |
| PMA | P910056 |
| Supplement | S010 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |