FDAFebruary 27, 2018device
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 evaluat...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
What to do
FDA enforcement status: Terminated
Brands named
iridex
Recall history
No related federal recalls on record for this brand yet.
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →