Events

Alerta De Seguridad para Catalys Precision Laser System

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
    2015-03-16
  • Fecha de publicación del evento
    2015-03-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150316a.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 catalys precision laser system medical device manufacturer, abbott medical optics, has issued a medical device safety alert concerning catalys precision laser system [software version: 3.00.05]. the manufacturer identified two issues: loss of suction during treatment which may result in scoring the cornea during lens fragmentation. for the cataract incision surgeon templates with software version 3.00.05, selecting and deselecting an eye then selecting the other eye will result in templates for both eyes having the same parameters. the manufacturer has provided instructions on how to detect and respond to loss of suction, and advised users to verify the parameters, architecture and location of the cataract incisions in the cataract incision surgeon templates before saving and before treatment. the manufacturer will provide a software update to resolve the second issue. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

Catalys Precision Laser System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Medical Optics Catalys Precision Laser System
  • Manufacturer
    Abbott Medical Optics

Manufacturer

Abbott Medical Optics