Events

Retiro De Equipo (Recall) de Device Recall 1Day Acuvue Moist contact lenses for Astigmatism

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
    60810
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0734-2012
  • Fecha de inicio del evento
    2011-12-01
  • Fecha de publicación del evento
    2012-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106522
  • 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
    Johnson & johnson vision care, inc. recalled their 1-day acuvue moist brand contact lenses for astigmatism due to a lot being mixed. the secondary carton lot number and power are not the same as on the primary package inside the carton.
  • Acción
    The firm, Johnson & Johnson Vision Care, sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated 1 December 2011 to all consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their practice/store inventory for product affected by this discrepancy in labeling; if you dispensed this product to a patient; contact the patient and replace lenses to all intended visual correction and performance with the correct lens power; complete and return ACKNOWLEDGEMENT OF RECEIPT Form via fax to: 904-443-3442 or email: VPIWEB@visus.jn.com and return any cartons labeled with the noted lot number to Customer Relations. Johnson & Johnson will replace them with the correct product. For any questions regarding this labeling situation, contact Customer Relations at 1-800-843-2020.

Device

Device Recall 1Day Acuvue Moist contact lenses for Astigmatism
  • Modelo / Serial
    External carton Lot Number B00BVTN -1.50 -1.25cyl. 100¿ (30 primary packages per secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80¿ (30 primary packages per secondary carton)
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: NY and FL and countries of: Finland, France, Germany, Italy, Netherlands, Norway, Denmark, Switzerland, Sweden, and the United Kingdom.
  • Descripción del producto
    Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" || Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" || It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-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