FDA product code · Ophthalmic
Lens, Intraocular, Phakic
2 FDA decisions since 2004. 8 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MTA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in MTA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report