Important Update Regarding Voluntary Recall of Allergan's ZEN 45
As of Friday October 18th, 2019, Allergan reached out to surgeons to inform them that unused XEN 45 devices are on hold in the U.S. and globally. Consequently, the Company recommended surgeons postpone any upcoming surgeries using XEN and not implant any unused XEN devices currently in their practice/office/surgical suite/OR. Since then, Allergan has voluntarily recalled all lots of XEN® Glaucoma Treatment System (XEN® 45 Gel Stent preloaded into a XEN® Injector). Healthcare providers will receive a recall letter by October 31, 2019 to return unused XEN products. Allergan has informed the U.S. Food and Drug Administration of this voluntary recall.
This recall is being conducted down to the Retail (Health Care Provider) Level. It is important to note that explanting implanted devices is not being recommended; this recall is a retrieval of un-implanted inventory.
During in-process inspection, 4 (four) units in an unreleased XEN® 45 lot were observed to have trace amounts of residual polishing compounds that are used in the needle sleeve manufacturing process. A review of the field safety reports has not detected any safety signals or adverse trends associated with the residual polishing compounds.
Allergan understands this recall has caused an interruption and inconvenience to customers and patients, but its first priority is always patient safety.
For any question regarding XEN or to report any adverse events, please contact Product Surveillance at 1-800-624-4261. Allergan anticipates resupply of XEN45® to the U.S. market in mid-December.