PMA · Approved
ApprovedArtisan (Model 206 and 204) Phakic Intraocular Lens (Piol) Verisyse (VRSM5US and VRSM6US) Phakic Intraocular Lens (Piol)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophtec BV · MTA Lens, Intraocular, Phakic
Approved on Sep 10, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 437-day review.
- Decided
- Sep 10, 2004
- Review
- 437 days
- Class
- Class III
- Product code
- MTA
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030028 has 11 supplements since 2010: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2018 | 3 |
| 2019 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MTA devicesMTA Lens, Intraocular, Phakic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MTA
Too few MTA 510(k)s in any year since 2007 to give a median.
Recalls per year · MTA
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTA
655in 2025
MAUDE reports naming product code MTA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 7 | — | 0 | 226 |
| 2009 | 3 | — | 0 | 601 |
| 2010 | 5 | — | 0 | 551 |
| 2011 | 4 | — | 0 | 311 |
| 2012 | 2 | — | 0 | 500 |
| 2013 | 1 | — | 0 | 696 |
| 2014 | 2 | — | 0 | 781 |
| 2015 | 2 | — | 0 | 1,279 |
| 2016 | 0 | — | 0 | 1,456 |
| 2017 | 5 | — | 0 | 1,796 |
| 2018 | 3 | — | 0 | 1,778 |
| 2019 | 6 | — | 0 | 1,236 |
| 2020 | 1 | — | 0 | 1,440 |
| 2021 | 1 | — | 0 | 2,063 |
| 2022 | 4 | — | 0 | 1,917 |
| 2023 | 0 | — | 7 | 2,076 |
| 2024 | 4 | — | 0 | 2,148 |
| 2025 | 2 | — | 0 | 655 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/P030028 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030028: Artisan (Model 206 and 204) Phakic Intraocular Lens (Piol) Verisyse (VRSM5US and VRSM6US) Phakic Intraocular Lens (Piol).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030028
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026