Events

Safety Alert for Arcotane 5ml

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Arcadophta SARL.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-12-17
  • Event Date Posted
    2015-12-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151217.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: arcadophta sarl arcotane 5ml the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning arcotane 5ml with the lot number 9433347 manufactured by arcadophta sarl. the manufacturer is issuing an urgent recall of arcotane perfluoro-n-octane due to reports of three cases of inexplicable severe vision loss after uneventful retinal detachment surgery during which the perfluoro-n-octane arcotane device has been used. as a conservative measure, the manufacturer has decided to perform a recall of all the lots that are potentially linked to these three cases. according to the alert, at present there is no evidence whether the product arcotane is potentially the cause of the unfortunate vision loss in the three cases reported. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01229-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 december 2015.

Device

Arcotane 5ml
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Arcadophta SARL Arcotane 5ml
  • Manufacturer
    Arcadophta SARL

Manufacturer

Arcadophta SARL