KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ellex 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-2013-RN-01254-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-13
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    The manufacturer, acufocus is aware of reports of some cases involving use of ophthalmic laser applications in eyes containing kamra inlays. during laser treatment, the inlay may absorb the laser and produce heat. this may result in the inlay reducing in size and/or significant thermal damage. in some cases, there were secondary damage to the cornea resulting in scarring. as a result of these case reports, ellex is providing additional warnings and information relative to the application of various ophthalmic procedures with a kamra inlay in situ.
  • 조치
    The manufacturer has advised the inlays are not defective and function as intended. The purpose of this notification is to provide additional warnings and information with regard to further treatment to patients implanted with the KARMA inlay.

Device

  • 모델명 / 제조번호(시리얼번호)
    KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))ARTG Number: 182104
  • Manufacturer

Manufacturer