Events

Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System) 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-01184-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01184-1
  • 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 received complaints for the infiniti ultrasound paks related to occlusion of the aspiration line. the investigation identified equipment misalignment during manufacturing which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the infiniti ultrasound paks. alcon is conducting this medical device recall due to the fact that the possibility exists for a loss of aspiration flow and / or occlusions of the aspiration line during surgery which may pose a safety risk to patients.
  • 조치
    Alcon is requesting the users to immediately stop further use and segregate the affected lots of INFINITI Ultrasound PAKs. Replacement stock will be issued for units that are returned to Alcon. This action has been closed-out on 18/03/2016.

Device

Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Proc...
  • 모델명 / 제조번호(시리얼번호)
    Alcon INFINITI Ultrasound PAKs - INFINITI Microsmooth Tapered Kelman 30°(Ophthalmic Surgical Procedure Kit used with INFINITI Vision System) Catalogue Number: 8065750280Lot Number: 1628714HARTG number: 141454
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd