FDA product code · Ophthalmic
Extended Depth Of Focus Intraocular Lens
1 FDA decision since 2016. No recall names this code.
Intended to be implanted to replace the natural lens of an eye.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of POE 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 · POE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POE
Too few POE 510(k)s in any year since 2007 to give a median.
Recalls per year · POE
No recall names POE since 2007.
Adverse event reports per year · POE
440in 2025
MAUDE reports naming product code POE, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 110 |
| 2017 | 0 | — | 0 | 754 |
| 2018 | 0 | — | 0 | 799 |
| 2019 | 0 | — | 0 | 735 |
| 2020 | 3 | — | 0 | 347 |
| 2021 | 1 | — | 0 | 598 |
| 2022 | 6 | — | 0 | 635 |
| 2023 | 3 | — | 0 | 551 |
| 2024 | 0 | — | 0 | 523 |
| 2025 | 3 | — | 0 | 440 |
| 2026 | 1 | — | 0 | — |
Planning a device in POE? 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) ReportRelated product codes
Other codes under 21 CFR 886.3600.