Events

Alerta De Seguridad para Proclear Toric Soft Hydrophilic Contact Lenses

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

¿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
    2014-10-03
  • Fecha de publicación del evento
    2014-10-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141003.html
  • 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
    Medical device safety alert: coopervision proclear toric soft hydrophilic contact lenses the australia therapeutic goods administration (tga) posted a medical device safety alert concerning proclear toric soft hydrophilic contact lenses manufactured by coopervision. the manufacturer's investigation of the complaints received have identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. according to the manufacturer, there is no added medical risk to an incorrect axis lens use, since the patient will notice the blur and visual disturbance right away and report it to the practitioner. replacement of the lens with the proper power parameter in sphere and cylinder, and/or axis of astigmatism will alleviate the visual blur and disturbance. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01039-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

Proclear Toric Soft Hydrophilic Contact Lenses
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Coopervision Proclear Toric Soft Hydrophilic Contact Lenses
  • Manufacturer
    Coopervision

Manufacturer

Coopervision