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 modification to the labeling for the visian® implantable collamer® lens, models micl and tmicl to reflect the findings of the adverse event post-approval study for the visian® micl
| Device | Visian ICL (Implantable Collamer Lens) |
| Classification Name | Lens, Intraocular, Phakic |
| Generic Name | Lens, Intraocular, Phakic |
| Applicant | STAAR Surgical Company |
| Date Received | 2018-11-02 |
| Decision Date | 2019-04-15 |
| PMA | P030016 |
| Supplement | S036 |
| Product Code | MTA |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STAAR Surgical Company 1911 Walker Ave. monrovia, CA 91016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030016 | Original Filing | |
| S043 | 2022-04-04 | Normal 180 Day Track No User Fee |
| S042 | ||
| S041 | 2021-06-22 | 30-day Notice |
| S040 | 2020-03-03 | 30-day Notice |
| S039 | 2019-06-27 | 30-day Notice |
| S038 | 2019-05-21 | Normal 180 Day Track No User Fee |
| S037 | ||
| S036 | 2018-11-02 | Normal 180 Day Track No User Fee |
| S035 | ||
| S034 | 2018-10-11 | Normal 180 Day Track No User Fee |
| S033 | 2017-07-06 | 30-day Notice |
| S032 | 2017-06-27 | 30-day Notice |
| S031 | 2017-05-19 | 30-day Notice |
| S030 | 2017-01-05 | 30-day Notice |
| S029 | 2015-11-12 | 30-day Notice |
| S028 | 2015-10-19 | 30-day Notice |
| S027 | 2014-04-14 | Normal 180 Day Track |
| S026 | 2014-01-13 | 30-day Notice |
| S025 | 2013-03-12 | Normal 180 Day Track No User Fee |
| S024 | ||
| S023 | 2012-02-29 | Normal 180 Day Track No User Fee |
| S022 | 2011-12-16 | Normal 180 Day Track No User Fee |
| S021 | ||
| S020 | 2011-03-30 | 30-day Notice |
| S019 | 2010-12-23 | Normal 180 Day Track |
| S018 | 2010-10-14 | Normal 180 Day Track No User Fee |
| S017 | 2010-08-17 | Special (immediate Track) |
| S016 | 2010-07-15 | 30-day Notice |
| S015 | 2010-06-25 | 30-day Notice |
| S014 | 2010-05-17 | 30-day Notice |
| S013 | ||
| S012 | 2009-02-09 | 30-day Notice |
| S011 | 2008-10-09 | 30-day Notice |
| S010 | 2008-08-04 | 30-day Notice |
| S009 | 2008-07-23 | 135 Review Track For 30-day Notice |
| S008 | 2008-06-06 | 30-day Notice |
| S007 | 2008-04-25 | 30-day Notice |
| S006 | 2008-04-02 | Normal 180 Day Track |
| S005 | 2008-03-28 | 30-day Notice |
| S004 | 2008-03-20 | 30-day Notice |
| S003 | 2008-02-22 | 30-day Notice |
| S002 | ||
| S001 | 2006-04-28 | Panel Track |