Events

Recall of Abbott Medical Optics (AMO) STAR Excimer Laser System

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-00567-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00567-1
  • 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
    There is the potential for an inadvertent laser firing with no surgeon interaction on the foot pedal due to incorrect output of electrical foot switch buffer when the following conditions are present:1- circuit breaker c9 is tripped open, causing a remote panel pcb power loss2- normal system interlocks are cleared (system waiting for surgeon intervention)there have been no reports of inadvertent firing of the laser in the field.
  • Action
    Abbott Medical Optics is replacing the circuit board component of all STAR Excimer Laser Systems. The manufacturer has advised that the devices may continue to be used to treat patients. In the unlikely event that the system initiates treatment without direct input, physicians are advised to immediately use the Laser Stop Button located on the doctor's panel as described in the Operators Manual.

Device

Abbott Medical Optics (AMO) STAR Excimer Laser System
  • Model / Serial
    Abbott Medical Optics (AMO) STAR Excimer Laser SystemModels: S3, S4 and S4 IR
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd