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