The FDA has issued a notice on the April 13 conviction of two men for selling unapproved surgical sterilization devices that caused 18 patients to lose sight in one eye.
Ross Caputo and Robert Riley, executives at AbTox, received permission for their company to "market a small gas plasma sterilizer only for use in sterilizing flat stainless-steel surgical instruments without lumens (tubes) or hinges," the notice said. But "the defendants instead marketed a larger, unauthorized version of the sterilizer and promoted its use for a wide array of non stainless-steel instruments."
An investigation conducted by the FDA's Office of Criminal Investigations led to the convictions of the defendants on "three counts of wire fraud, four counts of mail fraud, seven counts of selling an adulterated (unapproved) or misbranded (mislabeled) human medical device, and conspiracy to defraud the FDA," the notice said.