Events

Recall of Stellaris PC with Laser System (Cataract extraction/vitrectomy system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bausch & Lomb Australia Pty Ltd.

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
    RC-2014-RN-01205-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01205-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The stellaris pc has a software fault, when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo to endo continuous) and the system is in “standby”, the system will automatically transition from “standby” to “ready” to fire. if the system moves to ready from standby, and this has not been specifically commanded by the surgeon or the nurse, it raises the possibility that this change may not have been noticed and that the foot pedal could be depressed and the laser may fire unexpectedly.
  • Action
    Bausch and Lomb has developed a software update to address the situation, which will be installed in the affected system. In the meantime, users may continue to use the Stellaris PC laser system. However, they are advised not to request the Laser sub-mode change from Endo to Endo Continuous during surgery until the software update has been implemented. This action has been closed-out on 06/06/2016.

Device

Stellaris PC with Laser System (Cataract extraction/vitrectomy system)
  • Model / Serial
    Stellaris PC with Laser System (Cataract extraction/vitrectomy system)Product Code: BL14304Serial Number : SPC02059ARTG Number: 127264
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd