Events

Recall of XEN-45 GLAUCOMA TREATMENT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SALIENT MEDICAL SOLUTIONS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    120806
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-16
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Surgeons may encounter a higher than expected force to actuate slider mechanism on some xen injectors when they are in the process of implanting the xen 45 gel stent which may lead to ocular trauma especially when surgeon forces slider mechanism forward.

Device

XEN-45 GLAUCOMA TREATMENT SYSTEM
  • Model / Serial
    Model Catalog: 5507-001 (Lot serial: 60869); Model Catalog: 5507-001 (Lot serial: 60815)
  • Product Description
    XEN 45 Glaucoma Treatment System
  • Manufacturer
    SALIENT MEDICAL SOLUTIONS

Manufacturer

SALIENT MEDICAL SOLUTIONS