FDA product code · Ophthalmic
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
1 FDA decision since 2017. No recall names this code.
The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PZK 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 · PZK
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZK
Too few PZK 510(k)s in any year since 2007 to give a median.
Recalls per year · PZK
No recall names PZK since 2007.
Adverse event reports per year · PZK
444in 2025
MAUDE reports naming product code PZK, 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 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 7 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 18 |
| 2021 | 7 | — | 0 | 88 |
| 2022 | 2 | — | 0 | 77 |
| 2023 | 8 | — | 0 | 121 |
| 2024 | 8 | — | 0 | 260 |
| 2025 | 9 | — | 0 | 444 |
| 2026 | 4 | — | 0 | — |
Planning a device in PZK? 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.