Allergan has issued a voluntary recall of a small quantity (15 units) of Xen glaucoma treatment system (Xen 45 Gel Stent preloaded into a Xen injector). Four units in an unreleased Xen 45 lot were found to have trace amounts of residual polishing compounds used in the needle sleeve manufacturing process.
As a precautionary measure, Allergan has issued a Xen 45 product hold 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. Allergan asks healthcare providers to continue routine post-operative follow up and report any adverse events to Allergan’s product surveillance +1 (800) 433-8871.
