Medical device manufacturer, Bausch & Lomb, Inc., has initiated a voluntary product recall concerning disposable cannulas with 4-digit lots numbers provided with Amvisc and Amvisc Plus.
Bausch & Lomb, Inc. recently identified that some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus ophthalmic viscosurgical device (OVD) are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The disposable cannulas with 4-digit lot numbers may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury.
This recall is limited to cannulas with 4-digit lot numbers pre-packaged with some Amvisc and Amvisc Plus sodium hyaluronate in sterile glass syringes. It does NOT include cannulas with 8-digit lot numbers pre-packaged with some Amvisc and Amvisc Plus OVD, nor does it include the Amvisc or Amvisc Plus OVD in the glass syringes themselves.
The manufacturer advised the users to discontinue the use of the affected products immediately. The affected products should continue to be refrigerated, but placed in quarantine.
According to the local supplier, the affected devices were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 16 November 2012