Events

Perspective Hitech intraocular lenses 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 NMM 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
    2006-01-10
  • 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-lots-de-lentilles-intra-oculaires-de-la-societe-pht-industries
  • 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 company NMM (buyer of the company PHT INDUSTRIES) withdraws from the market all batches of the medical device called "Perspective Hitech intraocular lenses" references PM601, A60P, T65, AP12, AP13, SOF6, HQ203 marked CE 0434 following several complaints mainly focused on refractive errors .. The company has directly notified the recipients concerned with the message attached (10/01/2006) (19 KB) validated by the Afssaps .. The T65 implants manufactured by NMM and marked CE 0120 are not concerned by this reminder. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. This reminder relates only to France.

Device

Perspective Hitech intraocular lenses
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    NMM

Manufacturer

NMM
  • Source
    LAANSM