Bausch + Lomb lands Class I recall status after broken syringes harm patients

January 24, 2013 by MassDevice staff

Medical device maker Bausch + Lomb gets the FDA's highest-risk recall label over syringe components that have, in rare instances, broken during injection and left patients with serious injuries.

Bausch + Lomb logo

Eye care giant Bausch + Lomb received the FDA's highest-risk classification for a recall of several lots of sterile cannulas after a few patients were seriously injured with the small tubes detached from syringes during injection.

The FDA gave the recall Class I status, generally reserved for recalls which "involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA notice.

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Bausch + Lomb's 27G disposable cannulas are packaged with Amvisc and Amvisc Plus ophthalmic viscosurgical devices. The cannulas are attached to a glass syringe that delivers a thick, gel-like substance to the front of the eye or behind the iris as an aid during eye surgery.

The company began notifying customers of the issue in November 2012, and is asking healthcare providers to stop using the cannulas and destroy or quarantine remaining products from the affected lots, according to the recall notice.

That's bad news for the eye products maker, which is currently for sale at a sticker price of about $10 billion, according to reports that began circulating late last year.