Events

Alerta De Seguridad para TECNIS 1-Piece Intraocular Lenses

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott Medical Optics.

¿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
  • Fecha
    2016-09-02
  • Fecha de publicación del evento
    2016-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160902b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: abbott medical optics tecnis 1-piece intraocular lenses medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning its tecnis 1-piece intraocular lenses (iols). [model: zcb00; diopter 24.5; serial number: 4651021512]. the manufacturer has become aware of a small number of tecnis iols that may have been mislabeled during the manufacturing process. the manufacturer is initiating this action due to detection of an inspection equipment malfunction that resulted in lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabeled iols. according to the manufacturer, use of a mislabeled iol could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. the likelihood of any impact to the patients is very low. product recall is on-going. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 september 2016.

Device

TECNIS 1-Piece Intraocular Lenses
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Medical Optics TECNIS 1-Piece Intraocular Lenses
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics