Alerta De Seguridad para 1 Day Acuvue® TruEye™ (Narafilcon B) Contact Lenses

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Johnson & Johnson Vision Care, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2011-12-23
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: johnson & johnson vision care 1 day acuvue® trueye™ (narafilcon b) contact lenses contact lenses manufacturer, johnson & johnson vision care, inc., is conducting a product recall for two lots of 1-day acuvue® trueye™ (narafilcon b) brand contact lenses due to a lot mix/mislabel. the secondary carton lot number and power (diopter) are not the same as on the primary package inside the carton. the returned secondary cartons were labeled lot number 1450625718 (-1.75) but actually contained product from lot number 1451810217 (-1.00). the manufacturer is conducting a recall of products with the aforementioned two lot numbers. according to johnson & johnson vision care (hk), hong kong does not distribute this brand of contact lenses. if you are in possession of the affected product, please contact your supplier for more information.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Johnson & Johnson Vision Care 1 Day Acuvue® TruEye™ (Narafilcon B) Contact Lenses
  • Manufacturer

Manufacturer