Device 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.
Z-1075-2018
Product summary
- Event
- Event 79386
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 58 OUS - 46
- Official record key
device-enforcement:Z-1075-2018
Official wording
Reason: It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Code information: Device Identity : 87300, 87301, 87302, 87303, 87304
Distribution pattern: Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Derived failure modes
-
Unknown
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.