Reported Mar 28, 2018 · Terminated
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope…
Iridex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iridex Corporation · 1212 Terra Bella Ave · Mountain View, CA · 94043-1824
Is this the product you have?
- 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.
- Lot codes and dates
- Device Identity
8730087301873028730387304
- Device Identity
- Amount recalled
- US - 58 OUS - 46
Why it was recalled
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Iridex Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.