This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the visian icl (implantable collamer lens) models micl12. 1, micl12. 6, micl13. 2 and micl13. 7. The device is indicated for adults 21-45 years of age: 1) to correct myopia ranging from -3. 0 diopters to
| Device | VISIAN ICL (IMPLANTABLE COLLAMER LENS) |
| Classification Name | Lens, Intraocular, Phakic |
| Generic Name | Lens, Intraocular, Phakic |
| Applicant | STAAR Surgical Company |
| Date Received | 2003-05-08 |
| Decision Date | 2005-12-22 |
| Notice Date | 2006-08-25 |
| PMA | P030016 |
| Supplement | S |
| Product Code | MTA |
| Docket Number | 06M-0340 |
| Advisory Committee | Ophthalmic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | STAAR Surgical Company 1911 Walker Ave. monrovia, CA 91016 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |