Events

Retiro De Equipo (Recall) de Device Recall AquaRefresh

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 Marietta Vision.

¿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
    58008
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1557-2011
  • Fecha de inicio del evento
    2011-02-21
  • Fecha de publicación del evento
    2011-03-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97962
  • 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
    Accessories, soft lens products - Product Code LPN
  • Causa
    Product is misbranded; product labeled as, made in the netherlands, was actually manufactured in mexico.
  • Acción
    John Patterson, President of Marietta Vision called each optical retailer on February 21, 2011, and told them of the misbranding issue in regards to country of origin. In addition, an Urgent Product Recall letter was sent to each account on February 23, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their AquaRefresh inventory for lot number KD005, and discontinue distribution of the samples immediately and to return any outstanding stock to Marietta Vision for exchange. Marietta Vision would return the misbranded product back to the Mexican factory at their expense to have the product packaging corrected. If they elect not to do so, Marietta Vision would have the product disposed of. Customers were instructed to fax the enclosed form back to Marietta Vision at 678-797-1099. For questions regarding this recall call 866-300-6257.

Device

Device Recall AquaRefresh
  • Modelo / Serial
    Lot Number: KD005
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AR, AZ, CA and TX.
  • Descripción del producto
    AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. || Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses
  • Manufacturer
    Marietta Vision

Manufacturer

Marietta Vision
  • Dirección del fabricante
    Marietta Vision, 397 N Sessions St Nw, Marietta GA 30060-1325
  • Source
    USFDA