FDA recall Z-1075-2018

Iridex Corporation · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2018-02-27
Report date: 2018-03-28
Termination date: 2023-09-22
Voluntary/Mandated: FDA Mandated
Location: Mountain View, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2018