Events

Retiro De Equipo (Recall) de Device Recall Horizon

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 American Optisurgical 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
    52697
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1808-2009
  • Fecha de inicio del evento
    2009-03-24
  • Fecha de publicación del evento
    2009-09-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83671
  • 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
    phacoemulsification system - Product Code HQC
  • Causa
    Device operation interrupted: a software bug causes phaco to stop when vacuum goes above 300 mmhg while in multi burst mode. use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.
  • Acción
    American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.

Device

Device Recall Horizon
  • Modelo / Serial
    Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.
  • Descripción del producto
    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Dirección del fabricante
    American Optisurgical Inc, 25501 Arctic Ocean Dr, Lake Forest CA 92630
  • Empresa matriz del fabricante (2017)
    American Optisurgical Inc
  • Source
    USFDA