IRIDEX issues voluntary recall of TruFocus LIO Premiere ophthalmoscope
On February 23, IRIDEX initiated a voluntary recall of a specific laser accessory called the TruFocus LIO Premiere. The LIO is a headmounted indirect ophthalmoscope that connects to an IRIDEX laser console and is used to view and perform laser treatments on a patient's eye. There are 104 TruFocus LIO Premiere units at customer sites worldwide. The Company has received reports of three adverse events occurring during procedures in which the TruFocus LIO Premiere was used. These reports stated that the procedures resulted in patients experiencing permanent damage to the eye, including focal cataracts and iris burns. Customers who have the TruFocus LIO Premiere should stop using it. IRIDEX is notifying its distributors and customers via FedEx and is arranging for return of all recalled products. Recalled products were manufactured from May 26, 2017 to November 6, 2017 and distributed from June 5, 2017 to January 29, 2018.