Alcon Valved Entry System 3CT, 23Ga and 25Ga 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Alcon Laboratories Inc 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
    19003
  • 사례 시작날짜
    2015-08-27
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Alcon Laboratories Australia Pty Ltd (NZ), c/- Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland
  • 원인
    The manufacturer advises that specific lots of its single-use 23 gauge and 25 gauge valved entry systems have the potential to leak beyond their design specification. leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (iop) in patients.
  • 조치
    Manufacturer to issue advice regarding use

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 8065 751 657 (23Ga), 8065 751 658 (25Ga), Affected: Selected lots
  • Manufacturer

Manufacturer