Events

Recall of Arcadophta SARL– Arcotane 5ml

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-01229-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01229-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, arcadophta sarl, is issuing this urgent recall of arcotane perfluoro-n-octane due to reports of three (3) cases of inexplicable severe vision loss after uneventful retinal detachment surgery during which the perfluoro-n-octane arcotane device has been used. at present there is no evidence whether the product arcotane is potentially the cause of the unfortunate vision loss in the three (3) cases reported, however as a conservative measure, arcadophta has decided to perform a recall of all the lots that are potentially linked to these three (3) cases.
  • Action
    DTA is advising users to review inventory and quarantine any of the affected lot for return to DTA. This action has been closed-out on 05/09/2016.

Device

Arcadophta SARL– Arcotane 5ml

Manufacturer

Device Technologies Australia Pty Ltd