Recall Z-1075-2018 ยท GEX Powered Laser Surgical Instrument
Iridex Corporation
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.
| Date | Feb 27, 2018 |
| 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. |
| Root cause | Device Design |
| 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 qu |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170718 | Iridex TruFocus LIO Premiere Iridex Corporation, May 3, 2017 |