Z-1075-2018 Class II Terminated
FDA device recall Z-1075-2018 was initiated by Iridex Corporation on February 27, 2018 and is designated Class II. 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. The recall status is terminated (terminated September 22, 2023). Affected quantity: US - 58 OUS - 46.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- February 27, 2018
- Termination Date
- September 22, 2023
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 58 OUS - 46
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.
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 Pattern
Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
Code Information
Device Identity : 87300, 87301, 87302, 87303, 87304