Events

Retiro De Equipo (Recall) de Device Recall Insight Instruments MIS ( MultiPort Illumination System)

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 Insight Instruments, 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
    64887
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1281-2013
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2013-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117276
  • 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
    Cannula, Ophthalmic - Product Code HMX
  • Causa
    Insight instruments, inc., stuart, fl is recalling m.I.S. (multi-port illumination system), ophthalmic cannula due to a misclassification of the medical device.
  • Acción
    Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.

Device

Device Recall Insight Instruments MIS ( MultiPort Illumination System)
  • Modelo / Serial
    Lot Numbers: M53157, M55115, M56929, M58551, M61862.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution IN and IL
  • Descripción del producto
    Insight Instruments MIS ( Multi-Port Illumination System) || Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.
  • Manufacturer
    Insight Instruments, Inc.

Manufacturer

Insight Instruments, Inc.
  • Dirección del fabricante
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Empresa matriz del fabricante (2017)
    Insight Instruments, Inc.
  • Source
    USFDA