Eye Surgery Machine Recalled by FDA

eyesurgery-300x226The FDA has issued a recall in certain ophthalmic microsurgical devices due to hardware and software errors which can lead to blindness or eye injuries.

In a prepared statement the FDA stated that the devices in question are known to have error messages, non responsive screens, performance problems and also unexpected shutdowns. On July 2nd mail was sent to all customers by Alcon Laboratories informing them of the urgent recall. They also said that Alcon representatives will be sent to all sites and would update and replace all malfunction and error software and hardware. The devices will also not be removed from healthcare facilities stated by the agency.

Included in the recalled devices are Vision System Without Laser, Vision System with Laser, Tabletop and models T, L, X, B, LX, LXT, LT and XT. These devices are used to provide various types of eye surgeries. The level of recall, Class I includes the devices which may have defects and errors which can and may lead to surgical mishaps and can cause serious damage or even death to patients who may undergo the surgical procedure. The Alcon Research LTD located in Irvine states that the recall will be effective immediately and all location sites will have their devices functional .