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 ASCRS.
Allergan stated that 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 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,” according to the statement.