Events

Retiro De Equipo (Recall) de Occulentis BV - IOL

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Oculentis BV.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    21966
  • Fecha de inicio del evento
    2017-09-13
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    The manufacturer has indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the iol. although the cause of iol opacification is multifactorial, remnants could make the iol under certain conditions more prone to opacification.
  • Acción
    Product to be returned to supplier

Device

Occulentis BV - IOL
  • Modelo / Serial
    Model: , Affected: model numbers starting with L-, LU-, LS- expiry date between 2017-01 and 2020-05.
  • Manufacturer
    Oculentis BV

Manufacturer

Oculentis BV