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.
Recall
- Recall Number
- Z-1075-2018
- Event Number
- 79386
- Firm
- Iridex Corporation
- FEI Number
- 2939653
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 27, 2018
- Terminated
- September 22, 2023
- Address
- 1212 Terra Bella Ave, Mountain View, CA, 94043-1824
Description
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.
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
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
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
US - 58 OUS - 46