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 labeling change to include the addition of a new intraocular lens (iol) inserter, inj100, in the directions for use.
| Device | AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2013-04-15 |
| Decision Date | 2013-07-01 |
| PMA | P060022 |
| Supplement | S016 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |
|---|---|---|
| P060022 | Original Filing | |
| S030 | 2022-08-16 | 30-day Notice |
| S029 | 2021-12-22 | 30-day Notice |
| S028 | 2020-12-04 | 30-day Notice |
| S027 | ||
| S026 | ||
| S025 | 2019-12-23 | 30-day Notice |
| S024 | 2018-07-10 | 30-day Notice |
| S023 | 2016-06-03 | 30-day Notice |
| S022 | 2015-09-11 | 135 Review Track For 30-day Notice |
| S021 | 2015-02-18 | 30-day Notice |
| S020 | 2014-12-08 | Real-time Process |
| S019 | 2014-05-15 | 30-day Notice |
| S018 | ||
| S017 | 2013-06-10 | 30-day Notice |
| S016 | 2013-04-15 | Real-time Process |
| S015 | 2013-02-22 | 30-day Notice |
| S014 | 2012-08-20 | 30-day Notice |
| S013 | 2012-03-20 | Real-time Process |
| S012 | 2011-06-21 | Normal 180 Day Track |
| S011 | 2011-05-09 | 30-day Notice |
| S010 | 2011-02-16 | Normal 180 Day Track No User Fee |
| S009 | 2011-03-18 | 30-day Notice |
| S008 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S007 | 2010-04-30 | 30-day Notice |
| S006 | 2010-01-29 | Real-time Process |
| S005 | 2009-08-25 | 30-day Notice |
| S004 | 2009-03-06 | 30-day Notice |
| S003 | ||
| S002 | 2008-10-24 | Real-time Process |
| S001 | 2008-10-20 | 30-day Notice |