Events

Recall of LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation (used during ophthalmic surgical procedure for cataract, retina and cornea)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Alcon Laboratories 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-2015-RN-00757-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00757-1
  • 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
    Alcon is undertaking a recall for product correction of all lx3 microscope floor stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message (4xx), and/or resulting in illumination failure. alcon will retrofit the cable design on any impacted lx3 microscope floor stands. loss of system functionality during surgery due to issues within the microscope modules or illumination failure will result in the loss of visualisation by the surgeon during the procedure, which can lead to the potential for patient injury. this could include scleral/corneal trauma, intraocular tissue damage, capsule injury, retinal tear/detachment, endothelial cell damage, corneal oedema or intraocular bleeding.
  • Action
    Alcon is retrofitting all affected devices with a new cable design. Alcon is recommending that if users choose to continue to use the affected devices before the correction has been performed, to ensure an alternative microscope and light source is available. This action has been closed-out on 17/08/2016.

Device

LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microsc...
  • Model / Serial
    LX3 Microscope Floor Stand used with the LuxOR Ophthalmic Microscope and LuxOR Ophthalmic Microscope with Q-VUE 3D Assistant Visualisation (used during ophthalmic surgical procedure for cataract, retina and cornea)Product Code: 8065752560ARTG Number: 210550
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd