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Iridex Corporation recalls Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmosco
Recalled March 28, 2018 · FDA recall Z-1075-2018 · Iridex
Hazard
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. · FDA Class II
Units
US - 58 OUS - 46
Sold at
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Description
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
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.
Manufacturer(s)
Iridex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →