Events

Alerta De Seguridad para Algerbrush- II and its accessories

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

¿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
    2016-11-28
  • Fecha de publicación del evento
    2016-11-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161128.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: bausch & lomb algerbrush- ii and its accessories medical device manufacturer, bausch & lomb, has issued a medical device safety alert concerning algerbrush- ii and its accessories [product description (part number): 1) algerbrush-ii 0.5mm (e0815 a) ; 2) algerbrush-ii 1.0mm (e0815 b); 3) burr/chuck replaces 0.5mm (e0815 0.5); 4) burr/chuck replaces 1.0mm (e0815 1.0); 5) pterygium burr medium diamond (e0816 c)]. an internal investigation by the manufacturer found that the operating instructions packed with the product are missing or out of date. the manufacturer advises users that the algerbrush-ii can continue to be used following the updated sterilization instructions provided in the field safety notice. the new operating instructions now contain specific time and temperature for sterilization. failure to follow the new revised operating instruction can result in potential adverse events including eye infections. the manufacturer will send the updated operating instruction (rev.3 april 2012) to all affected customers. 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 28 november 2016.

Device

Algerbrush- II and its accessories
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Algerbrush- II and its accessories
  • Manufacturer
    Bausch & Lomb

Manufacturer

Bausch & Lomb