Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted recall — FDA Z-1075-2018
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
Overview of recall records associated with Iridex Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 1.
It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
This page summarizes recall records in which the official source identifies Iridex Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.