FDA product code · Ophthalmic
Phakic Toric Intraocular Lens
0 FDA decisions since 2018. 4 recalls name this code, 0 of them Class I.
Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QCB 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 · QCB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QCB
Too few QCB 510(k)s in any year since 2007 to give a median.
Recalls per year · QCB
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QCB
1,384in 2025
MAUDE reports naming product code QCB, 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 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 1,102 |
| 2020 | 0 | — | 0 | 1,757 |
| 2021 | 0 | — | 0 | 2,887 |
| 2022 | 0 | — | 0 | 2,795 |
| 2023 | 0 | — | 4 | 3,703 |
| 2024 | 0 | — | 0 | 3,605 |
| 2025 | 1 | — | 0 | 1,384 |
| 2026 | 0 | — | 0 | — |
Planning a device in QCB? 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.