Events

AcrySof CACHET PHAKIC Lens 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-01013-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01013-1
  • 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 are discontinuing the cachet phakic lens based on data analysis from an ongoing 10-year study to evaluate the safety of the cachet phakic lens in patients with myopia (near-sightedness) from -6.0 to -16.5 d vision correction. the clinical data analysis indicates an increase in the number of cases of endothelial cell loss (ecl). in the clinical study, patients’ endothelial cell density (ecd) levels are monitored at 6 month intervals, as recommended by the current cachet phakic lens directions for use (dfu). to date, only 2.7% of the 1,323 cachet phakic lenses implanted in the clinical study were explanted due to ecl.
  • 조치
    If you have inventory of the CACHET Phakic Lens, these lenses can be returned to Alcon for reimbursement. Patients with the CACHET Phakic Lenses already implanted, Alcon is recommending opthamologists adhere to the monitoring requirements described in the current DFU. Adherence to these requirements will help to timely identify significant ECL and determine the appropriate treatment plan. For more details, please see http://www.tga.gov.au/safety/alerts-device-acrysof-cachet-phakic-lens-140924.htm .

Device

AcrySof CACHET PHAKIC Lens

Manufacturer

Alcon Laboratories Australia Pty Ltd