Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
XEN Gel Stent Recalled by Allergan PLC Due to Foreign Object Contamination
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Allergan PLC directly.
Affected Products
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.
Quantity: 145,711 Glaucoma Treatment Systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Allergan PLC
Allergan PLC has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report