Events

Retiro De Equipo (Recall) de Device Recall 1DAy ACUVUE MOIST contact lens

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 Johnson & Johnson Vision Care, 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
    64468
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1335-2013
  • Fecha de inicio del evento
    2012-12-21
  • Fecha de publicación del evento
    2013-05-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116214
  • 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
    Limited number of individual contact lens packages may not have been completely sealed.
  • Acción
    The firm, Johnson & Johnson, Vision Care, Inc. sent a letter dated January 9, 2013 to all their consignees stating the following actions: " Please contact your patients that may have received any of the affected product and instruct them to discontinue use immediately and return product to you for replacement " Please return the enclosed Business Reply Card (BRCl confirming for our records that you have received this notice, and indicating whether or not you have in stock, or have distributed to patients, any product from the lots noted above. " Please return any remaining affected product in your possession using the enclosed pre-paid mailer. " Pass this notice on to anyone in your practice that needs to be informed " Customer service will arrange for the return and replacement of any affected product. If you have any questions and/or if replacement lenses are needed, please contact customer Service (1-800-87 4-5278).

Device

Device Recall 1DAy ACUVUE MOIST contact lens
  • Modelo / Serial
    Lot Numbers:  2054890422, +2.25D 2054890521, + 2.25D 2054895620, + 2.25D 1536500620, -3.75D 2138800422, -4.75D
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.
  • Descripción del producto
    1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. || The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
  • Manufacturer
    Johnson & Johnson Vision Care, Inc.

Manufacturer

Johnson & Johnson Vision Care, Inc.
  • Dirección del fabricante
    Johnson & Johnson Vision Care, Inc., 7500 Centurion Pkwy, Jacksonville FL 32256-0517
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA