Events

COMPLETE® MoisturePLUS 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 AMO 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
    2007-06-01
  • 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-tous-les-lots-de-solution-complete-moisture-plus-amo
  • 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
    AMO voluntarily recalls COMPLETE® MoisturePLUS maintenance solutions. This recall follows a report by the American Center for Disease Control and Prevention (CDC), where the risk of Acanthamoeba keratitis (current water amoeba) for users of this solution is estimated to be seven times higher (2 cases per year). million) for non-users. Although no contamination of the product has been established to date, and the risk of infection is very low, AMO, as a precautionary measure, recommends to patients to change maintenance solution while waiting for further information. This recall does not apply to other AMO products. The competent authorities have been informed by the company. This message is intended for pharmacists, ophthalmologists (01/06/2007) (110 ko) and opticians (01/06/2007) (113 ko).

Device

COMPLETE® MoisturePLUS
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Ophthalmic Devices
  • 제품 설명
    medical_device
  • Manufacturer
    AMO

Manufacturer

AMO