Events

Retiro De Equipo (Recall) de Device Recall 56 1 Day Silicone Hydrogel (10 pack)

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 CooperVision 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
    79755
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1517-2018
  • Fecha de inicio del evento
    2018-02-21
  • 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=163247
  • 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
    Lens, contact, (disposable) - Product Code MVN
  • Causa
    The secondary packaging is labeled with an incorrect expiration date.
  • Acción
    The firm, CooperVision, sent an "Firm Initiated Voluntary Removal - ACTION REQUIRED" letter to its customers on 2/21/18. The letter describes the product, problem and actions to be taken. The letters instructed customers to: Examine your inventory for any affected lot numbers; Stop any further distribution of the specified lot(s) of clariti 1 day and Fresh Day contact lenses; discard product and contact CooperVision, Inc. Customer Service department at 1-800-341-2020 to receive credit and/or complimentary replacement product. The removal only affects clariti 1 day lenses with the lot numbers specified on the enclosed letter. No other clariti 1 day and Fresh Day products  or any other CooperVision products  are affected. If you have any further questions, please feel free to contact your Account Representative or Customer Service at 1-800-341-2020, 9:00 AM  7:00 PM ET, Monday - Friday.

Device

Device Recall 56 1 Day Silicone Hydrogel (10 pack)
  • Modelo / Serial
    Lot 14364100237018, Exp. Date 9/30/2020 (foil); 9/30/2022 (carton)
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
  • Descripción del producto
    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses || The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
  • Manufacturer
    CooperVision Inc.

Manufacturer

CooperVision Inc.
  • Dirección del fabricante
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA