Events

IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Carl Zeiss 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-01070-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01070-1
  • 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
    The ulib database delivered with new devices as well as the ulib database offered between march 25 and september 24, 2013 for download contained an erroneous value for one lens. this could lead to the implantation of a lens with a wrong diopter value. specially the a0 constant of the lens amo sensar ar40e is listed as 0.0 in the internal lens database of the iolmaster. the correct value is -2.420. the a0 value is only relevant if the haigis-formula or haigis-l-formula are used. therefore, users that use the amo sensar ar40e and one of the two haigis formulas are affected.
  • 조치
    Carl Zeiss is providing users with instructions on how to correct the a0 constant of the AMO Sensar AR40E on the affected IOLMaster systems and instructions on how to download the corrected database.

Device

IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and ...
  • 모델명 / 제조번호(시리얼번호)
    IOLMaster (used for the treatment of axial length, corneal curvature, anterior chamber depth and for the determination of the white-to-white distance (WTW) of the human eye, as well as for the calculation of the required intraocular lens)ARTG Number: 128166
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd