Iridex Corporation recalls Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope wh…

Recall date

February 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1075-2018

FDA classification

Class II

Brand / firm

Iridex Corporation

Sold / distributed

Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar

Why it was recalled

It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.