FEB 27, 2018
Cataract/Anterior Segment, Comprehensive Ophthalmology, Retina/Vitreous
Iridex has voluntarily recalled its TruFocus LIO Premiere laser accessory following 3 reports of permanent vision loss from focal cataracts and retinal burns during laser treatments with the device, according to an announcement on the company’s website. The LIO is a headmounted indirect ophthalmoscope that connects to an IRIDEX laser console.
The company is urging clinicians to stop using TruFocus LIO Premiere ophthalmoscopes with part numbers 87300, 87301, 87302, 87303 and 87304. Recalled products were distributed from June 5, 2017 to January 29, 2018.
Iridex has notified the Food and Drug Administration of the recall, and has asked distributers and customers to return the 104 TruFocus LIO Premiere units currently in circulation worldwide. Questions can be directed to the company’s technical support team at +1-844-357-9485 (United States), +1-650-962-8100 (international) or email@example.com.
Physicians and patients can report adverse reactions or quality issues to the FDA through the MedWatch Adverse Event Reporting site or by mail or fax (1-800-FDA-0178).