Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Johnson & Johnson Vision Care 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 003 11 17 000
  • 사례 시작날짜
    2017-11-02
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11703
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    A limited number of confirmed reports has been received by the manufacturer of a lens being ‘off power’ which the consumer may recognize as not accurately correcting the vision in one eye (some distortion or blurriness). upon investigation, it was determined that inserts within the mold used for manufacturing were damaged when making the front and back curve molds of the contact lens. johnson & johnson vision care has implemented improved inspection techniques for the identification of damaged inserts within the molds. not all lenses in these lots are affected and there is no significant health risk related to this issue.

Device

ACUVUE® OASYS® Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR® PLUS
  • 모델명 / 제조번호(시리얼번호)
    Product Specification: BC 8.6, -6.00D/-1.75D/170 Lot Number : B00GW4Z
  • 제품 설명
    Contact Lenses, Vision Corrective
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • 제조사 대표
    Allied Medical International
  • Source
    SFDA