Events

Recall of Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ellex Medical 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-2016-RN-00301-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00301-1
  • 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 has identified a potential defect in the fixed laser eye safety filter assembly for the above laser systems. under certain conditions there is potential for the glass of the safety filter optics to crack on their lower edge due to pressure applied on them by their retaining plate which in turn could damage the laser safety coating on the optics.The safety filter is located on the binocular mount of the delivery head, and is in the user’s optical viewing path and as such provides protection to the user’s eyes from any diffused reflected laser light during the laser treatment.There is a risk associated that if the above failure mode occurs, there is a remote possibility that during laser treatment the user could be exposed to any diffused reflected laser light.
  • Action
    Ellex Medical is advising users to check the affected devices to see if there is any green laser light visible while firing the laser. If so, remove the device from use and notify Ellex. Ellex will be replacing the filters on all affected systems with a newly designed filter. This action has been closed-out on 27/01/2017.

Device

Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System ...
  • Model / Serial
    Integre S Surgical frequency doubled Nd YAG laser system and Retinal Rejuvenation Therapy System (2RT) Model Numbers: LP5532 and LR1532Multiple Serial Numbers affectedARTG Number: 106758 and 224484
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd