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.
FDA Recall Z-1075-2018 · Posted None
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Recalling FirmIridex Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2018-02-27
Date Terminated2023-09-22
Product QuantityUS - 58 OUS - 46
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.
Firm Action
Action Taken by IRIDEX:
1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions.
2. A ship hold was initiated on November 15, 2017.
3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere.
4. Public Warning
A press release was prepared and sent out on February 23, 2018.
For further questions please call (650) 962-8848 Ext. 3672
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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