Class II — Iridex Corporation
| Recalling firm | Iridex Corporation |
|---|---|
| Registered facility | Iridex Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. |
| Product | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients. |
| Quantity | US - 58 OUS - 46 |
| Distribution | Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar |
| Initiated | 2018-02-27 |
| Classified | 2018-03-16 |
| Terminated | 2023-09-22 |
| Recall number | Z-1075-2018 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Iridex Corporation (Z-1075-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79386/
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