Events

Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AMO 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-2017-RN-00524-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00524-1
  • 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
    There is the possibility that due to a packaging error, 20ga vitrectomy cutters may be found in a 25ga package and 25ga vitrectomy cutters may be found in a 20ga package. use of a vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.
  • 조치
    AMO Australia is advising users to immediately stop using and remove from their inventory all affected lots of the Vitrectomy Cutter. AMO will arrange for return of affected product and replacement.

Device

Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation Sleeve
  • 모델명 / 제조번호(시리얼번호)
    Vitrectomy Cutter20GA Vitrectomy Cutter and Irrigation SleevePart Number: NGP0020Lot Number: CA0618025GA Vitrectomy CutterPart Number: NGP0025Lot Number: CA06182ARTG Number: 93352
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd