Events

Retiro De Equipo (Recall) de Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear

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 The See Clear Company.

¿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
    76279
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1404-2017
  • Fecha de inicio del evento
    2017-01-06
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152629
  • 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
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Sterility and misbranding: lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
  • Acción
    The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.

Device

Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
  • Modelo / Serial
    All lots of lenses sold between 10/31/2013 to 10/31/2016
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
  • Descripción del producto
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
  • Manufacturer
    The See Clear Company

Manufacturer

The See Clear Company
  • Dirección del fabricante
    The See Clear Company, 4995 Buford Hwy Ste 102, Peachtree Corners GA 30071-2721
  • Source
    USFDA