CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

TruFocus LIO Premiere" Laser Indirect Ophthalmoscope recalled by Iridex

Iridex is recalling Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a. The recall was initiated on 27 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Identity : 87300, 87301, 87302, 87303, 87304
Quantity recalledUS - 58 OUS - 46

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1075-2018
FDA event ID
79386
Recalling firm
Iridex, Mountain View, CA
Classification
Class II
Status
Terminated
Recall initiated
27 Feb 2018
FDA classified
16 Mar 2018
Reported
28 Mar 2018
Type
FDA Mandated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

27 Feb 2018Recall initiated by company
16 Mar 2018Classified by FDA+17 days
28 Mar 2018Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Questions about this recall

Is TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted recalled?

Yes. Iridex recalled TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted on 27 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1075-2018.

Why was it recalled?

It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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