Events

TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00 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-2016-RN-01151-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01151-1
  • 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
    Abbott has become aware of a small number of tecnis 1-piece iols (two in australia) that may have been mislabelled with the wrong diopter power. this is due to an inspection equipment malfunction during manufacturing. there is potential for lenses to have out of specification diopter or resolution. use of a mislabelled iol could lead to potential unexpected post-operative refractive error.
  • 조치
    Abbott are advising surgeons that if there were no issues identified during routine post-operative follow up, no further action is required regarding the implanted IOL. This action has been closed-out on 12/05/2017.

Device

TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00
  • 모델명 / 제조번호(시리얼번호)
    TECNIS 1-Piece Intraocular Lens (IOL) with TECNIS iTEC Preloaded Delivery System PCB00 Serial Numbers: 7138311403 and 7139121403ARTG Number: 203780
  • Manufacturer
    AMO Australia Pty Ltd

Manufacturer

AMO Australia Pty Ltd