Events

Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic 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-2015-RN-00751-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00751-1
  • 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
    It has been identified that a small percentage of the 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. the occurrence of a leaking valved cannula is easily detectable to the user intra-operatively as there will be visible leaking of fluid/saline solution from the entry point of the cannula prior to performing surgery.
  • 조치
    To prevent fluctuations of IOP during surgery, surgeons can use the Constellation Vision System’s IOP control feature. Alternatively a plug can be inserted the valve entry system. Alcon is providing standalone plugs to be inserted into affected valve entry systems in the event that unwanted leakage is detected. This action has been closed-out on 17/08/2016.

Device

Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments...
  • 모델명 / 제조번호(시리얼번호)
    Alcon 23 Gauge and 25 Gauge Valved entry systems (cannulas designed to allow entry of instruments to the back of the eye during ophthalmic surgery)Valved Entry Systems sold as standalone and contained within CONSTELLATION TOTALPLUS Paks and Alcon CUSTOM-PAKS Product Numbers:8065 751 585, 8065 751 586, 8065 751 657, 8065 751 658, 8065 751 900, 8065 751 902, 8065 751 908, 8065 751 910ARTG Number: 148011 and 145666
  • Manufacturer
    Alcon Laboratories Australia Pty Ltd

Manufacturer

Alcon Laboratories Australia Pty Ltd