Events

Alerta De Seguridad para Hydrophobic Monofocal Lens with Injector BIOTECH

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Biotech Vision Care Pvt. Ltd..

¿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
  • ID del evento
    I1701-22
  • Número del evento
    2013DM-0010831
  • Fecha
    2017-01-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=105
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected the possibility of finding particles in the referenced device that do not come from the lens of the injector, although they are not toxic nor represent a danger to the patient, but they can lead to delays in the surgical procedures.

Device

Hydrophobic Monofocal Lens with Injector BIOTECH
  • Modelo / Serial
  • Descripción del producto
    It is a high precision optical device, manufactured by machining. These lenses and tension rings are designed to be surgically implanted in the human eye as a replacement for the lens. The extraction of the natural or crystalline lens can be done with any of the existing techniques, manually (extracapsular) or by phacoemulsification.
  • Manufacturer
    Biotech Vision Care Pvt. Ltd.

Manufacturer

Biotech Vision Care Pvt. Ltd.
  • Source
    NIDFSINVIMA