Mountain View, CA, United States
Iridex Corporation recalls
1 recall recorded since 2018, most recently on 27 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 27 February 2018
- Terminated
- 22 September 2023
- Reason
- 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
- Initiated
- FDA Mandated
- Recall number
- Z-1075-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.