■ Allergan has initiated a voluntary recall of its Xen 45 glaucoma drainage device after a small number of units in an unreleased lot were observed to have trace amounts of polishing compounds that are used in the needle sleeve manufacturing process, according to a joint news release with the American Society of Cataract and Refractive Surgery. Xen 45 was approved by the FDA in 2016 as a treatment for refractory glaucoma.
Allergan said it has engaged regulatory agencies and is initiating a voluntary recall of affected lots of Xen 45. As a precautionary measure, Allergan issued a product hold of Xen 45 while investigating these findings. Allergan said it will provide additional information in the coming weeks on resupplying the market with newly manufactured lots of XEN 45.
Physicians are advised to continue routine postoperative follow-up and report any adverse events to Allergan Product Surveillance at 1(800)433-8871.