Iridex has issued a voluntary recall of its TruFocus LIO Premiere laser indirect ophthalmoscope following reports of three adverse events occurring during procedures, according to a press release.
Patients reportedly experienced permanent damage to the eye, including focal cataracts and retinal burns, the release said. Customers who have the product should stop using it, and the company is notifying distributors and customers to arrange for return of all recalled ophthalmoscopes.
The company has also notified the FDA of the recall.
Part numbers 87300, 87301, 87302, 87303 and 87304 are affected
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