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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01229-1
Product Name/Description	Arcadophta SARL– Arcotane 5ml Lot Number: 9433347 ARTG Number: 140539
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	15/12/2015
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	0417 419 268