Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) Recalled by Iridex Corporation Due to It was discovered that the laser energy was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Iridex Corporation directly.
Affected 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.
Quantity: US - 58 OUS - 46
Why Was This Recalled?
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Where Was This Sold?
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
About Iridex Corporation
Iridex Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report