Events

Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Alcon Laboratories 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-00613-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00613-1
  • 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
    Alcon is conducting a recall for specific lots and catalogue numbers of its centurion fms (fluidics management system) pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. the use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip.There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. there have been no reports of injuries associated with this issue.
  • 조치
    Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected product.

Device

Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the...
  • 모델명 / 제조번호(시리얼번호)
    Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery)Catalogue Numbers: 8065752180, 8065752181, 8065752200, 8065752201, 8065752917, 8065752918Lot Numbers: 1794105H, 1801726H, 1804659H, 1802316H, 1794157H, 1802311H, 1801714HARTG Number: 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd