Events

Alerta De Seguridad para Soft Contact Lenses

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 Coopervision Inc. (Ocular Sciences).

¿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
    R1501-20
  • Número del evento
    2007DM-0001254
  • Fecha
    2015-01-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the aforementioned medical devices may present problems because they contain lenses with an incorrect objective axis, which can cause blurred vision, leading to the generation of possible adverse events on the patient.

Device

Soft Contact Lenses
  • Modelo / Serial
    Biomedics Toric, lots 8246525202 and 8255525096.
  • Descripción del producto
    Soft contact lenses for extended use, programmed replacement OCUFILCON D SPHERE, ASPHERE and TORICO.BIOMEDICS 55 SPHERE UV PROTECTION AND EDGE III 55 are indicated for the correction of visual acuity in nonfaithful persons, without eye diseases, which manifest myopia, hyperopia and astigmatism. BIOMEDICS ASPHERE with UV protection are indicated for the correction of visual acuity in non-Afacic people, without diseases in the eyes and have been aspherised to control the longitudinal aberration of the lenses through the range of power. BIOMEDICS TORIC with UV protection are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-apothecary people without eye diseases.
  • Manufacturer
    Coopervision Inc. (Ocular Sciences)

Manufacturer

Coopervision Inc. (Ocular Sciences)