Events

LenSx Laser System (used for femtosecond 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-2014-RN-00424-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00424-1
  • 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 addressing reports of unexpected downward motion of the gantry. these reports are associated with systems manufactured with an older style motor/brake assembly. a new style motor/brake assembly (current version) has been used in manufacturing since may 2012. of the 41 reports, contact with the patient's eye or face was reported in three instances. in all of these cases, the contact with patient eye resulting from the unexpected downward gantry motion did not lead to a serious injury or a serious deterioration in state of health.
  • 조치
    If customers experience any unexpected gantry movement, they are advised to immediately notify Alcon and stop using the LenSx Laser System. Alcon will replace and install the current motor/brake assembly on any impacted LenSx Laser System manufactured prior to May 2012, including those that have not been previously upgraded.

Device

LenSx Laser System (used for femtosecond cataract surgery)
  • 모델명 / 제조번호(시리얼번호)
    LenSx Laser System (used for femtosecond cataract surgery) Serial numbers: 0611-A020, 0711-A022, 1011-A053, 1011-A060, 0312-A123ARTG Number: 181017
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd