Events

Alerta De Seguridad para Solution for Ophthalmic use - Healon Endocoat Viscoelastic Ophthalmic; VT 585; registration 80147060153; risk class IV, batches affected: 025582; 025521; 025514; 025652; 025658.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Produtos Óticos Ltda.; Lifecore Biomedical, LLC for Abbott Medical Optics Inc..

¿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
    1634
  • Fecha
    2015-07-08
  • 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
    According to the company, failure to follow the instructions for use could lead to trauma to the eye.
  • Causa
    Disconnection of the finger rest when pushing the plunger of the syringe. disengagement may result in unintended movement of the surgeon.
  • Acción
    The registrant advises that the instructions for use accompanying each device should be consulted for warnings, precautions and other important information for the use of the product. Specifically for this action, properly follow the additional instruction on the use of the syringe, contained in the attached alert message.

Device

Solution for Ophthalmic use - Healon Endocoat Viscoelastic Ophthalmic; VT 585; registration 80147...

Manufacturer

Abbott Produtos Óticos Ltda.; Lifecore Biomedical, LLC for Abbott Medical Optics Inc.