Drug recall
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO) The LIO is a headmounted indirect…
FDA recall event 79386 · Class II · Iridex Corporation
Key facts
| Event ID | 79386 |
|---|---|
| Recall numbers | Z-1075-2018 |
| Recalling firm | Iridex Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| 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. |
| Initiation date | Feb 27, 2018 |
| Report date | Mar 28, 2018 |
| Termination date | Sep 22, 2023 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 2939653 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: