Alerta De Seguridad para SINGLE USE DISPOSABLE CONTACT LENSES. All registrations granted by ANVISA.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    1259
  • Fecha
    2013-05-09
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    The manufacturer of single-use disposable lenses advises in their instructions for use what the indications, contraindications, adverse reactions, warnings and precautions are when using the product. Failure to observe recommended care may lead to severe eye problems, leading in some cases to loss of vision. Continuous use, use beyond the limit recommended by the manufacturer (these are single-use lenses), use without observing the necessary hygiene precautions when manipulated, significantly increases the occurrence of adverse events. Single use disposable lenses should not be reused. When the product is purchased, the user should be advised to seek medical attention if signs such as redness, blurring or any other visual changes occur, and symptoms such as pain, discomfort, foreign body sensation, or any other symptoms. You should also be warned about the importance of following the guidelines provided by the manufacturer.
  • Causa
    When using the product without the manufacturer's instructions being followed strictly, serious adverse user events may occur.
  • Acción
    Users of this type of product should be very careful about observing the instructions for use that accompany the product, avoiding the purchase of fractional products that do not have them.

Manufacturer

N/A
  • Source
    ANVSANVISA