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 artisan (model 206 and 204) phakic intraocular lens, also known as the verisyse (vrsm5us and vrsm6us) phakic intraocular lens to be distributed by advance medical optics. The device is indicated for: 1) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2. 5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3. 2 millimeters; and, 2) patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0. 50 diopters.
| Device | ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) |
| Classification Name | Lens, Intraocular, Phakic |
| Generic Name | Lens, Intraocular, Phakic |
| Applicant | OPHTEC BV |
| Date Received | 2003-07-01 |
| Decision Date | 2004-09-10 |
| Notice Date | 2005-01-21 |
| PMA | P030028 |
| Supplement | S |
| Product Code | MTA |
| Docket Number | 05M-0026 |
| Advisory Committee | Ophthalmic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | OPHTEC BV 6421 Congress Ave,suite 112 boca Raton, FL 33487 |
| 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 |
|---|---|---|
| P030028 | Original Filing | |
| S009 | 2022-02-08 | 30-day Notice |
| S008 | 2019-02-06 | Real-time Process |
| S007 | ||
| S006 | 2018-09-18 | 30-day Notice |
| S005 | 2017-01-23 | Normal 180 Day Track No User Fee |
| S004 | 2017-01-31 | Normal 180 Day Track No User Fee |
| S003 | 2012-01-05 | 30-day Notice |
| S002 | 2010-10-29 | 30-day Notice |
| S001 | 2009-11-25 | Normal 180 Day Track No User Fee |