Events

Retiro De Equipo (Recall) de CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ALCON CANADA 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
    16668
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-01
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Alcon has been informed by medtronic alcon's supplier of the devon light glove that medtronic is recalling specific lots of the devon light glove due to the potential for the glove to contain splits and holes. the devon light glove is included in specific builds of alcon custom-pak. based on the supplier information and recall initiated by the manufacturer of the devon light glove alcon has determined that the use of a torn/split light glove may pose a potential safety risk to the patient. due to the potential risk from using a torn/split devon light glove alcon is recalling all custom-paks built with the affected item.

Device

CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
  • Modelo / Serial
    Model Catalog: 00000-00 TO 99999-99 (Lot serial: LOTS LOWER THAN 17341874H); Model Catalog: 0000-00 (Lot serial: LOTS LOWER THAN 17341874H)
  • Descripción del producto
    CUSTOM-PAK OPHTHALMIC SURGERY PROCEDURE PACK
  • Manufacturer
    ALCON CANADA INC.

Manufacturer

ALCON CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    HC