Events

Alerta De Seguridad para Lenscare SH-System Monatslinsen monthly contact lenses

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por 4CARE GmbH.

¿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
    2013-11-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131120a.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
    Press release
  • Causa
    Safety alert over lenscare sh-system monatslinsen monthly contact lenses the department of health (dh) today (november 19) drew public attention to the recall of lenscare sh-system monatslinsen contact lenses because the surface of these lenses can get scratches during wearing and can even break. the dh, through its routine surveillance on medical devices, found that the united kingdom's medicines and healthcare products regulatory agency had posted a notice issued by a german manufacturer, 4care gmbh. according to the manufacturer, customer complaints for certain lot numbers of the products have increased recently. it was found that the surface of the lenses can get scratches during wearing and can even break. this may lead to foreign body sensation, blurred vision or eye irritation. the manufacturer advised users to stop using the products immediately. "the dh is following up with the manufacturer in germany to ascertain if the products have been distributed in hong kong. so far, the dh has not received any local reports of adverse events associated with the products," the spokesman said. "those customers who have purchased the said products should stop using them. they should consult health-care professionals for advice as soon as possible if they are either feeling unwell after using the products or in doubt," the spokesman added. the dh has informed public and private hospitals, relevant medical associations and optometrist associations about the issue. ends.

Device

Lenscare SH-System Monatslinsen monthly contact lenses
  • Modelo / Serial
  • Descripción del producto
    Press release: Safety alert over Lenscare SH-System Monatslinsen monthly contact lenses
  • Manufacturer
    4CARE GmbH

Manufacturer

4CARE GmbH
  • Source
    DH