Events

ACR6D intraocular lenses pre-loaded injector PREMIER 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 CORNEAL 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
  • 날짜
    2005-03-09
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lentilles-intra-oculaires-pre-chargees-en-injecteur-de-la-societe-corneal
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    The Afssaps was informed on March 1, 2005 by CORNEAL of the withdrawal of the market on February 18, 2005 from all lots of the medical device called "ACR6D intraocular lenses pre-loaded injector PREMIER" following an increase in cases. endophthalmitis and / or delayed inflammatory reactions. The company has directly notified the health facilities concerned with the attached message (01/03/2005) (7 ko). This reminder concerns only France, the incidents described above have been reported only in France, to date. The competent European authorities are informed by Afssaps.

Device

ACR6D intraocular lenses pre-loaded injector PREMIER
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    CORNEAL

Manufacturer

CORNEAL
  • Source
    LAANSM