FDAOctober 30, 2019device

XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds 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.

What to do

FDA enforcement status: Ongoing

Brands named

allergan plcallergan

UPCs

10888628032439

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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