WASHINGTON -- The FDA has issued a class I recall -- its most serious -- for certain devices in the Constellation Vision ophthalmic microsurgical systems line due to software and hardware power errors which may cause eye injury or blindness.
The ophthalmic microsurgical systems in question may experience unexpected power shutdowns, system error messages, unresponsive touchscreens, as well as setting and infusion performance problems, the FDA said in a prepared statement.
The manufacturer, Alcon Laboratories, contacted customers July 2 by mail announcing the urgent device recall.
The company informed those customers with affected devices that Alcon representatives would visit all system sites to update software, replace malfunctioning parts, and answer questions, the statement said.
The recall will not require the devices to be removed from any healthcare facility, the agency said in its brief.
The recall includes several different devices from the Constellation line, including the Vision System with Laser, Vision System Without Laser, Tabletop, and the Constellation models XT, LT, LXT, LX, B, X, L, and T.
The devices are used to provide a number of different types of eye surgery.
Class I recalls include devices and products with a reasonable probability of causing serious harm or death to patients.
Alcon Research LTD, the parent company of Alcon Laboratories, is located in Irvine, Calif.