Bausch + Lomb, an eye health product manufacturer based in Rochester, New York, received a recall notice from the United States Food and Drug Administration over its syringe components. The Class I recall, the highest-risk classification by the federal watchdog agency, was given to the company’s syringe components following severe patient injury.
According to a notice posted by the FDA, syringe components can break during injection. The recall impacts several lots of cannulas (small tubes that are used in conjunction with needles). According to the FDA, Class I status is reserved for product recalls that "involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The company’s 27G disposable cannulas are included with Amvisc ophthalmic viscosurgical devices. The cannulas are directly attached to a specialized glass syringe included with the devices. The cannulas deliver a gel-like substance to an area behind the iris or in front of the eye to assist surgeons during an operation.
Bausch + Lomb first notified customers of the risk in November of 2012. Healthcare providers have been informed that they should stop using the cannulas immediately. Any remaining product lots should be destroyed or quarantined.
Bausch + Lomb is currently for sale at $10 billion. With this latest recall, that sticker price may look like less of a bargain.