Events

Recall of Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve

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-2017-RN-00524-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00524-1
  • 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 possibility that due to a packaging error, 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package. use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.
  • Action
    AMO Australia is advising users to immediately stop using and remove from their inventory all affected lots of the Vitrectomy Cutter. AMO will arrange for return of affected product and replacement.

Device

Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve
  • Model / Serial
    Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation SleevePart Number: NGP0020Lot Number: CA0618025GA Vitrectomy CutterPart Number: NGP0025Lot Number: CA06182ARTG Number: 93352
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd