IRIDEX Corp. began a voluntary recall of its laser indirect ophthalmoscope TruFocus LIO Premiere after receiving reports of adverse events.
An indirect ophthalmoscope produces a reversed image of the eye for inspection of the interior of the eyeball. IRIDEX's product is a head-mounted indirect ophthalmoscope that connects to an IRIDEX laser console and is used to view and perform laser treatments on a patient's eye.
The manufacturer of laser devices for the ophthalmology market said it received reports of three adverse events occurring during procedures in which the device was used. The reports stated that the procedures resulted in patients experiencing permanent damage to the eye, including focal cataracts and iris burns.
California-based IRIDEX has notified the U.S. Food and Drug Administration of this action and is notifying its distributors and customers as well as arranging for the return of all recalled products. There are 104 product units at customer sites worldwide, the company said.
The recalled products were manufactured May 26-Nov. 6, 2017, and distributed June 5, 2017-Jan. 29, 2018.
In connection with the recall program, the company has revised its preliminary financial results for the fourth quarter and full year ended Dec. 30, 2017.
IRIDEX said total revenue for the fourth quarter of 2017 is expected to be $10.2 million to $10.3 million and total revenue for 2017 is expected to be $41.5 million to $41.6 million.