Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope — Class II medical device recall Z-1075-2018
Terminated recall by Iridex Corporation, reported 2018-03-28. It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts a
| Recall number | Z-1075-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Iridex Corporation, Mountain View, CA, United States |
| Recall initiated | 2018-02-27 |
| Classified | 2018-03-16 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2023-09-22 |
| Countries outside the US | AU, CA, CN, DE, IE, IL, JP, LB, QA |
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.
Reason for recall
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1075-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.