Events

EZ-Load Lens Delivery System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 iNova Pharmaceuticals 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-2017-RN-00520-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00520-1
  • 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
    Inova has identified an issue with two lots of the ez-load lens delivery system ez-28v, an intraocular lens inserter used to insert sofport intraocular lenses (iols). some inserters have been found to have a hook-like flash located near the tip area. this flash catches the leading haptic causing a kink. whilst mildly bent haptics can be restored to acceptable configuration intra-operatively using surgical instruments, a severely kinked haptic which cannot be restored can result in injury to the intraocular structures.
  • 조치
    iNova is advising users to inspect their stock of EZ-Load Lens Delivery System (EZ-28V) immediately and quarantine any affected lots. iNova will arrange for stock collection and will issue credit for returned stock.

Device

EZ-Load Lens Delivery System

Manufacturer

iNova Pharmaceuticals Australia Pty Ltd