Events

Retiro De Equipo (Recall) de Device Recall BioEye

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Integrated Orbital Implants Inc.

¿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
    36298
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0012-2007
  • Fecha de inicio del evento
    2006-02-27
  • Fecha de publicación del evento
    2006-10-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48367
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    orbital implant - Product Code HPZ
  • Causa
    The end label on the outer box was mislabeled on 9 of a 10 unit lot. the end label says ''22 mm'' and the implants are actually ''20 mm''. the main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
  • Acción
    The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.

Device

Device Recall BioEye
  • Modelo / Serial
    Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Internationally to Finland & France
  • Descripción del producto
    Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Dirección del fabricante
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
  • Source
    USFDA