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 addition of an aspheric surface to the approved parent crystalens iol model at-45. The device, as modified, will be marketed under the trade name crystalens models at50ao and at52ao and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed and is intended to provide near, intermediate, and distance vision without spectacles.
| Device | CRYSTALENS MODELS AT50AO AND AT52AO ACCOMMODATING INTRAOCULAR LENS (IOL) |
| Generic Name | Lens, Intraocular, Accommodative |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2009-08-26 |
| Decision Date | 2009-10-23 |
| PMA | P030002 |
| Supplement | S021 |
| Product Code | NAA |
| 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 |
|---|---|---|
| P030002 | Original Filing | |
| S040 | 2021-12-22 | 30-day Notice |
| S039 | ||
| S038 | 2016-02-01 | Normal 180 Day Track |
| S037 | 2015-12-18 | Normal 180 Day Track No User Fee |
| S036 | 2015-12-15 | Real-time Process |
| S035 | 2015-07-02 | Normal 180 Day Track No User Fee |
| S034 | 2015-04-01 | Normal 180 Day Track No User Fee |
| S033 | 2015-01-26 | Real-time Process |
| S032 | 2014-11-13 | 30-day Notice |
| S031 | 2014-04-14 | 30-day Notice |
| S030 | 2014-02-24 | 30-day Notice |
| S029 | 2014-01-16 | 30-day Notice |
| S028 | 2013-06-18 | Normal 180 Day Track No User Fee |
| S027 | 2012-03-27 | Panel Track |
| S026 | ||
| S025 | 2011-08-18 | 30-day Notice |
| S024 | 2011-07-14 | Real-time Process |
| S023 | 2011-02-24 | 30-day Notice |
| S022 | 2010-03-08 | Real-time Process |
| S021 | 2009-08-26 | Real-time Process |
| S020 | 2009-06-02 | Normal 180 Day Track |
| S019 | 2009-05-01 | Real-time Process |
| S018 | 2009-01-27 | 30-day Notice |
| S017 | 2008-08-07 | 30-day Notice |
| S016 | 2008-06-17 | 30-day Notice |
| S015 | 2008-05-15 | Normal 180 Day Track No User Fee |
| S014 | 2007-12-17 | Normal 180 Day Track |
| S013 | 2007-11-05 | Real-time Process |
| S012 | 2007-08-28 | 30-day Notice |
| S011 | 2007-04-25 | 30-day Notice |
| S010 | 2007-04-06 | Real-time Process |
| S009 | 2007-03-05 | Real-time Process |
| S008 | 2006-07-24 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2005-10-20 | Normal 180 Day Track No User Fee |
| S005 | 2005-08-23 | Special (immediate Track) |
| S004 | 2005-07-05 | Real-time Process |
| S003 | 2005-05-04 | Normal 180 Day Track No User Fee |
| S002 | 2004-08-30 | Special (immediate Track) |
| S001 | 2004-06-28 | Real-time Process |