Events

Arcadophta SARL– Arcotane 5ml 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-01229-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-12-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01229-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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