Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0598-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2019-10-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0598-2020
Date of alert
2019-10-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Allergan PLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888628032439
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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