Allergan collaborated with ASCRS on the release of the following statement pertaining to Allergan’s Xen glaucoma surgical drainage device.
During Allergan’s inspection process, a small number of units in an unreleased XEN 45 lot were observed to have trace amounts of polishing compounds that are used in the needle sleeve manufacturing process.
Allergan 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 is committed to patient safety and anticipates that this voluntary recall will begin in the coming days.
Allergan 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 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.
ASCRS continues to collaborate with Allergan and will provide the most up to date information as it becomes available.