Events

Alerta De Seguridad para Contact Lens AVAIRA - Model Avaira Sphere- Registration 80130430037 - Lots affected as per attachment. http://migre.me/6bIfq

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por COOPERVISION DO BRASIL LTDA..

¿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
    1100
  • Fecha
    2011-11-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    To date, there are no records of product-related notifications in the National Notification System for Health Surveillance - NOTIVISA. Anvisa is following this action.
  • Causa
    The manufacturer of the product has identified the presence of silicone residue in batches of the products mentioned, which can cause from oversight or discomfort to severe eye pain or injury requiring medical treatment. symptoms, however, may vary from individual to individual.
  • Acción
    For professional ophthalmologists and distributors, the company determines that affected lots are identified and segregated. To the patients, the search of their doctor for judicious evaluation.

Device

Contact Lens AVAIRA - Model Avaira Sphere- Registration 80130430037 - Lots affected as per attach...

Manufacturer

COOPERVISION DO BRASIL LTDA.