Allergan plc (NYSE: AGN) announced 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 ASCRS. Allergan stated that it has engaged regulatory agencies and is initiating a voluntary recall of affected lots of XEN 45.
According to the company, the “XEN® Gel Stent” is a surgical implant designed to lower high eye pressure in open-angle glaucoma patients where previous surgical treatment has failed and/or medications alone were insufficient (also known as refractory glaucoma). The device is marketed for the surgical management of refractory glaucomas, including cases where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. In a letter dated on October 30th, 2019, Allergan issued communication to customers, and through the company website, stated that fifteen (15) lots of XEN® Glaucoma Treatment System are to be recalled. Allergan also advised the U.S. Food and Drug Administration of the voluntary recall.
According to information from the company, an inspection found 4 (four) units in an unreleased XEN® 45 lot observed to have trace amounts of residual polishing compounds used in the needle sleeve manufacturing process. The device had been shipped with the product since January 19th, 2017. Allergan advised that “the residual polishing compounds on the XEN® injector needle assembly could transfer to the patient’s eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body. Signal detection review does not indicate an adverse trend associated with the residual polishing compounds”. An additional statement from Allergan said, “physicians are advised to continue routine post-operative follow up and report any adverse events to Allergan Product Surveillance at 1 (800) 433-8871. Allergan regrets any inconvenience this causes for you or your patients and appreciate your understanding as it works to resolve this issue swiftly and completely.”