Reports of serious injuries among eye surgery patients has resulted in the recall of dozens of lots of Bausch and Lomb sterile cannulas that were packed with Amvisc Sodium Hyaluronate, which is a surgical aid gel.
The Bausch and Lomb Amvisc Sodium Hyaluronate cannula recall was first announced in November, but the FDA determined this week that the action constitutes a Class I recall, suggesting that the recalled eye surgery product has a reasonable chance of causing serious injury or death.
The Bausch and Lomb cannula is a small, disposable tube filled with viscoelastic material and packaged with the Amvisc and Amvisc Plus Opthalmic Viscosurgical Device (OVD). It appears that some of the cannulas may leak during injection or detach from the syringe they are attached to in the package. The FDA warns that there have been instances where detachment led to serious patient injury.
The recall affects the Bausch and Lomb 27G sterile cannula packed in Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Bausch and Lomb Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. It is attached to a syringe of OVD by a standard luer fitting and was manufactured by Rhein Medical, Inc. of St. Petersburg Florida. The FDA Class I recall notice contains a complete list of lot numbers affected by the recall.
Bausch and Lomb has advised customers to discontinue the use of the cannulas and recommends that they be destroyed or that the products be quarantined under refrigeration until a sales representative can visit the customer’s site. Customers with questions can contact Bausch and Lomb, Inc. at (585) 338-8731.