Alerta De Seguridad para Avaira and BioComfort XO 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
    2011-11-16
  • 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
    Press release
  • Causa
    Recall of avaira and biocomfort xo contact lenses the department of health (dh) today (november 16) endorsed the recall of avaira and biocomfort xo contact lenses in hong kong as the product’s manufacturer in the united states, coopervision, has expanded its global recall of the avaira brand product line of contact lenses announced in august this year. a dh spokesman said the product’s local distributor, coopervision hong kong revealed that the lenses are being recalled because of the presence of silicone oil residue which may cause hazy vision or discomfort, severe eye pain or even eye injuries requiring medical treatment. the spokesman said that coopervision had recalled its avaira toric and biocomfort xo toric contact lenses in august this year, following complaints of discomfort and/or blurred vision from consumers. he further explained that in view of possible consumer safety concern and to avoid market confusion, a total recall of avaira and biocomfort xo contact lenses in hong kong is a prudent measure. dh will alert the hospital authority, private hospitals, relevant healthcare institutions, medical and optometrists associations about the matter. the company has also set up a hotline at 3718 0688 to answer enquiries. "members of the public should cease using the product if they feel unwell, and consult their healthcare providers. dh will continue the investigation and closely monitor the recall." ends/ wednesday, november 16, 2011.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Press release: Recall of Avaira and BioComfort XO contact lense
  • Manufacturer

Manufacturer