Events

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

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Johnson & Johnson Vision Care.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 003 11 17 000
  • Fecha de inicio del evento
    2017-11-02
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11703
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    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
  • Modelo / Serial
    Product Specification: BC 8.6, -6.00D/-1.75D/170 Lot Number : B00GW4Z
  • Descripción del producto
    Contact Lenses, Vision Corrective
  • Manufacturer
    Johnson & Johnson Vision Care

Manufacturer

Johnson & Johnson Vision Care
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Representante del fabricante
    Allied Medical International
  • Source
    SFDA