Events

Recall of Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery)

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-2016-RN-00613-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00613-1
  • 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 conducting a recall for specific lots and catalogue numbers of its centurion fms (fluidics management system) pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. the use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip.There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. there have been no reports of injuries associated with this issue.
  • Action
    Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected product.

Device

Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the...
  • Model / Serial
    Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery)Catalogue Numbers: 8065752180, 8065752181, 8065752200, 8065752201, 8065752917, 8065752918Lot Numbers: 1794105H, 1801726H, 1804659H, 1802316H, 1794157H, 1802311H, 1801714HARTG Number: 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd