Events

Recall of Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AMO 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-2013-RN-01093-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01093-1
  • 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 manufacturer is aware of an issue that has the potential to result in loss of illumination due to unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. this issue can be traced to overheating of a specific component found in a limited amount of star system, which can result in a burning smell coming from the laser system.
  • Action
    Abbott Medical Optics (AMO Australia) is advising users that the printed circuit board of the affected units will be replaced prior to 31 January 2014. AMO is advising users to contact the AMO service representative in the case a system has a loss of illumination.

Device

Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)
  • Model / Serial
    Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)Model Number: S4 IRSerial Number: 9271ARTG Number: 120575
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd