Events

Notificaciones De Seguridad De Campo acerca de ACUVUE® OASYS® for ASTIGMATISM Brand Contact Lenses

Según Inspectie Gezondheidszorg en Jeugd, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Netherlands que fue producido por Johnson & Johnson Vision Care Inc..

¿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
    Field Safety Notice
  • Fecha
    2017-10-26
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/10/26/johnson-and-johnson---acuvue-oasys-for-astigmatism
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    We received a limited number of confirmed reports 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.

Device

ACUVUE® OASYS® for ASTIGMATISM Brand Contact Lenses

Manufacturer

Johnson & Johnson Vision Care Inc.
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Comentario del fabricante
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ