Events

Recall of Constellation Pneumatic Handpiece, DSP (Ophthalmic surgical instrument handle)

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-2013-RN-00354-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00354-1
  • 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 forceps or scissors tips may dislodge from the handpiece, if not attached by the user according to the directions for use.
  • Action
    Alcon is asking customers to check their inventory and inform them, if there are any affected stock. An Alcon representative will be in contact to organise pick up of the affected handpieces.

Device

Constellation Pneumatic Handpiece, DSP (Ophthalmic surgical instrument handle)
  • Model / Serial
    Constellation Pneumatic Handpiece, DSP (Ophthalmic surgical instrument handle)Catalogue number: 725.01All lot numbers affectedARTG number: 196529
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd