Iridex Corporation: Medical Device Recall in 2018 - (Recall #: Z-1075-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 27, 2018

Date Posted: March 28, 2018

Recall Number: Z-1075-2018

Event ID: 79386

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.

Status: Terminated

Product Quantity: US - 58 OUS - 46

Code Information:

Device Identity : 87300, 87301, 87302, 87303, 87304

Distribution Pattern:

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

Voluntary or Mandated:

FDA Mandated