Iridex recalls TruFocus LIO Premiere laser ophthalmoscopes due to risk of focal cataracts and iris burns from improper laser energy delivery. Affected models include 87300-87304.
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Iridex is recalling its TruFocus LIO Premiere laser ophthalmoscopes because they can cause focal cataracts and iris burns. This happens when the laser energy doesn't reach the intended target during use, potentially harming the eye.
The laser energy in these ophthalmoscopes doesn't reach the intended target during use, causing focal cataracts and iris burns. This occurs because the laser energy is not properly focused, leading to unintended damage to the eye.
Medical professionals who use the TruFocus LIO Premiere laser ophthalmoscopes for eye examinations are most at risk. Patients receiving treatments with this device could also be affected.
Check for the model numbers 87300, 87301, 87302, 87303, or 87304 on the device. The TruFocus LIO Premiere is a head-mounted laser ophthalmoscope used for eye examinations.
Look for model numbers 87300 through 87304 on the device.
The laser energy does not reach the intended target during use, causing focal cataracts and iris burns.
Models 87300, 87301, 87302, 87303, and 87304.
The recall record does not specify a remedy, so contact Iridex Corporation for guidance.
We’ve drafted a message you can send Iridex to request your refund or repair — edit it as you like.
Subject: Recall Z-1075-2018 — Iridex Iridex Hello, I own a Iridex that is covered by recall Z-1075-2018 from Iridex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
