Events

Retiro De Equipo (Recall) de Device Recall Ocular Conformer

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 Porex Surgical, 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
    48722
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2302-2008
  • Fecha de inicio del evento
    2008-03-28
  • Fecha de publicación del evento
    2008-09-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72000
  • 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
    Conformer, ophthalmic - Product Code HQN
  • Causa
    The ocular conformers were distributed with an expired expiration date.
  • Acción
    Consignees were contacted by phone on 03/28/2008. A follow up letter was sent on/about 03/31/2008. Consignees were instructed to examine their inventory and to quarantine Ocular Conformers containing the affected lots. These units should be returned to Porex Surgical using a Return Authorization Number provided. If the units were distributed, consignees were advised to contact their customers and inform them of the recall. They were informed the recall was being conducted to the physician level. Contact Porex Surgical at 1-770-515-7735 for assistance.

Device

Device Recall Ocular Conformer
  • Modelo / Serial
    Catalog number: 9574, Lot number 001061103C, Catalog number 9548, Lot number 002010204-C, Catalog number 9549, Lot number 003061103C, Catalog number 9779, Lot number 002050804C and Catalog number 9780, Lot number 006101204-C.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    PA, Canada and Germany
  • Descripción del producto
    Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265. || The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
  • Manufacturer
    Porex Surgical, Inc.

Manufacturer

Porex Surgical, Inc.
  • Dirección del fabricante
    Porex Surgical, Inc., 15 Dart Rd, Newnan GA 30265-1017
  • Source
    USFDA