Events

Oculentis LENTIS HydroSmart foldable intraocular lens 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Oculentis GmbH 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
    17876
  • 사례 시작날짜
    2014-12-24
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • 원인
    Oculentis gmbh has received sporadic notifications of postoperative opacification of the lentis® hydrosmart iols in glass vials, resulting in a reported occurrence rate of 0.011% of all implanted hydrosmart iols since 2006., analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the iol material and the fluctuating, batch related presence of silicone residues on some iols. such residues may potentially change the iol surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. these deposits may compromise the optical transparency of the iol, potentially leading to a reduction in the patient's visual acuity.
  • 조치
    Product to be returned to supplier

Device

Oculentis LENTIS HydroSmart foldable intraocular lens
  • 모델명 / 제조번호(시리얼번호)
    Model: All IOL models starting with L-, LU-, or LS-, Affected: Serial numbers starting with 20000
  • Manufacturer
    Oculentis GmbH

Manufacturer

Oculentis GmbH