Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy
Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported injuries (focal cataracts and iris burns), which meets the criteria for a Severe rating (Score 4) under the rubric for FDA Class II with injury reports.
Plain-English summary
Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope (LIO). The LIO is a headmounted indirect ophthalmoscope 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.
The recall was initiated because it was discovered that the laser energy was not going where intended, resulting in focal cataracts and iris burns. The device is identified by device identity codes 87300, 87301, 87302, 87303, and 87304.
The recall covers 58 units in the United States and 46 units outside the United States. Distribution was worldwide, including the USA, China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel, and Qatar. Users should stop using the device and contact Iridex Corporation for further instructions.
The recalled product
- 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
- Manufacturer
- Iridex Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Device Identity : 87300
- 87301
- 87302
- 87303
- 87304
Distribution
Distribution scope not specified by the agency.
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