Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25260 |
| Brand Name: | Xen Glaucoma Treatment System(3 models) |
| Model: | XEN 45 Glaucoma Treatment System - Glaucoma shunt |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Allergan New Zealand Ltd Cnr Manu Tapu Drive & Joseph Hammond Place Auckland 2022 |
| Contact Information: | |
| Manufacturer: | Allergan Inc |
| Issue: | During routine in-process manufacturing inspection of the needle, trace amounts of polishing compounds were observed on the needle of an unreleased XEN® unit. Trace amounts of polishing compounds on the XEN® injector needle 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/10/2019 |
