Events

Recall of Stellaris PC Vision Enhancement 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-2012-RN-00917-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00917-1
  • 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
    Bausch & lomb recently determined that posterior fluidics modules (pfms) installed in the stellaris pc vision enhancement systems listed may need to be recalibrated. these modules, which regulated the performance of the vitrectomy probe, may exhibit behaviour that could result in less efficient aspiration.
  • Action
    Bausch & Lomb is providing work around instructions to mitigate the issue and will be replacing the posterior fluidics module to correct the problem.

Device

Stellaris PC Vision Enhancement System (Cataract Extraction/Vitrectomy System)
  • Model / Serial
    Stellaris PC Vision Enhancement System (Cataract Extraction/Vitrectomy System)Multiple serial numbers ARTG Number: 127264
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd