FDA product code · Ophthalmic
Lens, Multifocal Intraocular
5 FDA decisions since 1997. 3 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 MFK 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 · MFK
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MFK
Too few MFK 510(k)s in any year since 2007 to give a median.
Recalls per year · MFK
No recall names MFK since 2007.
Adverse event reports per year · MFK
717in 2025
MAUDE reports naming product code MFK, 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 | 13 | — | 0 | 35 |
| 2008 | 12 | — | 0 | 420 |
| 2009 | 14 | — | 0 | 586 |
| 2010 | 9 | — | 0 | 601 |
| 2011 | 10 | — | 0 | 584 |
| 2012 | 9 | — | 0 | 308 |
| 2013 | 9 | — | 0 | 296 |
| 2014 | 5 | — | 0 | 308 |
| 2015 | 3 | — | 0 | 708 |
| 2016 | 11 | — | 0 | 731 |
| 2017 | 12 | — | 0 | 613 |
| 2018 | 12 | — | 0 | 629 |
| 2019 | 8 | — | 0 | 683 |
| 2020 | 4 | — | 0 | 912 |
| 2021 | 8 | — | 0 | 1,205 |
| 2022 | 8 | — | 0 | 1,265 |
| 2023 | 6 | — | 0 | 1,047 |
| 2024 | 11 | — | 0 | 859 |
| 2025 | 14 | — | 0 | 717 |
| 2026 | 17 | — | 0 | — |
Planning a device in MFK? 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.