The cannulas may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury.
The United States Food and Drug Administration announced the recall on 23 January.
Due to its lubricating and viscoelastic properties, transparency and ability to protect corneal endothelial cells, Amvisc and Amvisc Plus help maintain anterior chamber depth and visibility, minimise interaction between tissues, and act as tamponade and vitreous substitutes during retina reattachment surgery. The 27-gauge disposable cannula is only used during surgery.
Health-care professionals, who often provide first-day post-operative care, should be aware of this potential for injury or complication during a surgical procedure.
Ms Jeanie Herbert, director of global surgical communications at Bausch + Lomb this week told Insight from California, “After receiving reports of adverse events related to 27G disposable cannulas with gray hubs provided with Amvisc and Amvisc Plus OVD, Bausch + Lomb initiated a voluntary global recall on 14 Novber for the affected cannula.
“This action included notifying health authorities and initiating notification to all affected customers. When doing so, we asked customers to check their product stock, quarantine affected lots, and confirm they have either destroyed the cannula, or asked Bausch + Lomb to do so for th. Since initiating the recall back in Novber, all affected lots and affected customers have been identified, and actions are currently underway to successfully resolve the matter.”
Ms Herbert went on to say, “Bausch + Lomb is committed to delivering products that are both safe and effective, and patient safety is paramount in everything we do.”
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