Iridex Issues Recall of TruFocus LIO Premiere Laser Indirect Ophthalmoscope

March 2, 2018: By Jon Swedien

Iridex has initiated a voluntary recall of its TruFocus LIO Premiere laser indirect ophthalmoscope.

The Mountain View, California, company announced the recall Feb. 23, after receiving reports of three adverse events during procedures using the laser accessory. Patients experienced permanent damage to the eye, including focal cataracts and iris burns, Iridex said.

The LIO is a head-mounted indirect ophthalmoscope that connects to an Iridex laser console and is used to view and perform laser treatments.

Customers should not use TruFocus LIO Premieres with part numbers 87300, 87301, 87302, 87303, and 87304, Iridex said. The company said there are 104 units at customer sites worldwide.

Iridex said it is notifying its distributors and customers via FedEx and is arranging for return of all recalled products. The company said it has notified the US FDA of the action.

Recalled products were manufactured from May 26, 2017, to Nov. 6, 2017, and distributed from June 5, 2017, to Jan. 29, 2018, the company said.

After the recall, Iridex revised its preliminary financial results for Q4-2017 and the full year.

Iridex’ total revenues for Q4-2017 are now expected to be between $10.2 million to $10.3 million. Iridex had expected the quarter’s total revenues to range from $11 million to $11.1 million.

The company’s total revenues for 2017 are expected to range between $41.5 million and $41.6 million after the recall. Previously, the company expected its 2017 revenues to range between $42.3 million and $42.4 million.

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