Events

Notificaciones De Seguridad De Campo acerca de AcrySof® IQ IOL with ULTRASERT Delivery System

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Alcon Laboratories, Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-07-29
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
    FSCA ID: 2016.069
  • Causa
    Alcon is initiating a medical device removal for specific lots of the acrysof® iq intraocular lens (iol) with ultraserttm delivery system. we are initiating this voluntary removal because we have determined the ultraserttm delivery systems from certain lots have an interior surface characteristic that could result in the iol becoming lodged in the ultraserttm delivery system. most likely if this happens the lens would not be delivered and the surgery could be completed with a standby lens; however, if the lens is forced through the nozzle this could result in damage to the lens and/or nozzle, possibly injuring the patient. please note that this event affects only a small portion of the ultraserttm delivery systems within the specified production lots. national competent authorities have been notified of this action. below please find the full details on this matter and directions for handling potentially-affected product in your practice. details on affected device: the acrysof® iq iol with ultraserttm delivery system is a ce marked medical device. the alcon acrysof® iq iol is an acrylic foldable single-piece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. the acrysof® iq iols are provided in the ultraserttm pre- loaded delivery system for a convenient, controlled means to reliably place these lenses into the capsular bag. .

Device

AcrySof® IQ IOL with ULTRASERT Delivery System
  • Modelo / Serial
    12409013
  • Descripción del producto
    SN60WF IN ULTRASERT DELIVERY SYSTEM
  • Manufacturer
    Alcon Laboratories, Inc.

Manufacturer

Alcon Laboratories, Inc.
  • Dirección del fabricante
    Alcon, farmacevtske storitve, d.o.o. Verovškova ulica 57 1000 Ljubljana Slovenija Tel.: +386 (0)1 422 5280
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    AMPMDRS