User experience with Xen shows device exposure as most common adverse event

Complications seen in practice after a device’s approval may differ from those seen in trials or reported in literature.
For Allergan’s Xen gel stent, the most common adverse events reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database between December 2016 and December 2019 were device exposure and device malposition, according to a poster presented at the virtual Women in Ophthalmology Summer Symposium.
“We identified 1,083 adverse events among 615 reports from December 22, 2016, to December 30, 2019,” Sarah H. Van Tassel, MD,

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