FDA slaps Class I tag on Bausch + Lomb's eye surgery recall
|Bausch + Lomb is recalling cannulas used in its Amvisc eye surgery devices--courtesy of Bausch + Lomb|
Bausch + Lomb is recalling cannulas shipped with its eye surgery devices over risks that they might leak or break during procedures, and the FDA has affixed its most serious designation to the affair, warning that malfunctions could cause serious injury in patients.
At issue are the disposable 27G cannulas packaged with Bausch's Amvisc ophthalmic viscosurgical device. The tubes are attached to a syringe during procedures like cataract surgery, but the company warns they may leak viscoelastic material or detach during injection, which has resulted in serious injury in a few cases, Bausch says.
The company is asking customers to either destroy or quarantine the affected tubes until they can be replaced, and the FDA is asking patients and physicians to report any adverse events through its online MedWatch system.
In the meantime, rumors are swirling of possible buyouts for the eye-care giant, as current owner Warburg Pincus is said to be considering deals. Big Pharmas such as Johnson & Johnson ($JNJ), Merck ($MRK) and Sanofi ($SNY) have expressed interest, according to reports, and Warburg is said to be asking for around $10 billion in exchange for Bausch.
Abbott Laboratories ($ABT), newly divested of its pharma operation, is also rumored to be eyeing a Bausch buyout to expand its offerings in stents and diagnostics.
- read the FDA's notice