FDA-Device2018-03-28Class II
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.
Iridex Corporation
Hazard
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Sold states
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Affected count
US - 58 OUS - 46
Manufactured in
1212 Terra Bella Ave, N/A, Mountain View, CA, United States
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 patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2018Don't want to check this manually?
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