Recall Z-1075-2018— Iridex Corporation
Class II · Terminated
Class II FDA medical device recall by Iridex Corporation, initiated 2018-02-27, terminated 2023-09-22. It names one FDA 510(k) clearance: K170718. 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: It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns..
- Recalling firm
- Iridex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-27
- Terminated
- 2023-09-22
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.