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 visian® toric icl (implantable collamer lens). The device is indicated for use in patients 21-45 years of age:1) for the correction of myopic astigmatism with spherical equivalent ranging from -3. 0d to less than or equal to -15. 0d (in the spectacle plane) with cylinder (spectacle plane) of 1. 0d to 4. 0d;2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15. 0d to -20. 0d (in the spectacle plane) with cylinder (spectacle plane) 1. 0d to 4. 0d;3. With an anterior chamber depth (acd) of 3. 00 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0. 5d for both spherical equivalent and cylinder for 1 year prior to implantation); and4) the visian® ticl is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
Device | Visian Toric ICL (IMPLANTABLE COLLAMER LENS) |
Classification Name | Phakic Toric Intraocular Lens |
Generic Name | Phakic Toric Intraocular Lens |
Applicant | STAAR Surgical Company |
Date Received | 2006-04-28 |
Decision Date | 2018-09-13 |
Notice Date | 2018-09-20 |
PMA | P030016 |
Supplement | S001 |
Product Code | QCB |
Docket Number | 18M-3503 |
Advisory Committee | Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
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 |