Events

Safety Alert for Stellaris PC Vision Enhancement System with Integrated Laser

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Bausch & Lomb.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-11-13
  • Event Date Posted
    2014-11-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141113.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bausch & lomb stellaris pc vision enhancement system with integrated laser medical device manufacturer, bausch & lomb, inc., has initiated a voluntary product recall concerning the stellaris pc vision enhancement system with integrated laser. the affected products are as follows: stellaris pc w/ laser: part number bl14304. stellaris pc w/ laser upgrade: part numbers bl1433 (stellaris pc w v3 software) with bl2272 (laser upgrade kit) and bl14334 (stellaris pc w v4 software) with bl2272 (laser upgrade kit). the manufacturer has identified a software anomaly where it can occur that when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo mode to endo continuous mode) and the system is in “standby”, the system will automatically transition to “ready” to fire state. this defeats one of the several safety mechanisms in the device to prevent inadvertent firing of the laser. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 november 2014.

Device

Stellaris PC Vision Enhancement System with Integrated Laser
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bausch & Lomb Stellaris PC Vision Enhancement System with Integrated Laser
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb