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IRIDEX Corporation (“Company”) 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.
The following part numbers have been recalled: 87300, 87301, 87302, 87303, and 87304.
IRIDEX has notified the U.S. Food and Drug Administration (FDA) of this action.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program.
As a consequence of this recall program, the Company has revised its preliminary financial results for the fourth quarter and full year ended December 30, 2017 to the following:
- Total revenue for the fourth quarter of 2017 is expected to be $10.2 to $10.3 million
- Total revenue for 2017 is expected to be $41.5 to $41.6 million
For Further Information
More on the interventional ophthalmic market in the U.S can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Interventional Ophthalmic Devices. The suite covers reports on the following markets: ophthalmic lasers, intraocular lenses (IOLs), phacoemulsification consoles, ophthalmic viscosurgical devices (OVDs) and glaucoma shunts.
The iData report series on ophthalmic devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about ophthalmic device market data, register online or email us at [email protected] for a U.S. Market Report Suite for Interventional Ophthalmic Devices brochure and synopsis.