FDA Device recall Z-1075-2018
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a h…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a h… by Iridex, citing it was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1075-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-27 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Iridex |
| Distribution | n/a |
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
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Identifiers
| code_info | Device Identity : 87300, 87301, 87302, 87303, 87304 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2018%22
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