Rochester, NY-Bausch + Lomb (B + L) has issued a Class I recall of cannulas packed in sodium hyaluronate ophthalmic viscosurgical device (OVD).
The recall includes certain lots of B + L 27G Sterile Cannula packed in either 1.2% sodium hyaluronate (Amvisc, Bausch + Lomb) (Model 59051, 59081, 59051L, 59081L) or 1.6 % sodium hyaluronate (Amvisc Plus, Bausch + Lomb) (Model 60081, 60051, 60051L, 60081L) OVD. Affected lot numbers are listed in the Recall Notice.
The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury.
B + L is advising customers to discontinue use of the product and either destroy or quarantine it under refrigeration pending a sales representative visit to their site.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Read the MedWatch safety alert, including a link to the Recall Notice, at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336466.htm.
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