Events

Retiro De Equipo (Recall) de Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)

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 Vistakon.

¿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
    56460
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2445-2010
  • Fecha de inicio del evento
    2010-07-16
  • Fecha de publicación del evento
    2010-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93722
  • 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, extended wear - Product Code LPM
  • Causa
    Acuvue oasys brand contact lenses for astigmatism may be mislabeled on the outer (secondary) packaging carton. the outer (secondary) cartons labeled as lot b006x641 -8.50d -1.25cyl. 100 axis may actually contain primary packages from lot b006wbs1 -9.00d -1.25cyl. 80 axis. the inner (primary) package labeling is correct. product was only distributed to eye care professionals for use in proper f.
  • Acción
    Vistakon issued an Important Product Notification dated July 28, 2010 to customers identifying the affected product, the labeling issue, and actions to be taken by the customer. Vistakon issued a separate Important Product Notification dated July 28, 2010 to distribuitors identifying the affected product, the labeling issue, and actions to be taken by the distributor. Customers are instructed to check their inventory for affected products and return a business reply card. If replacement -8.50 lenses are needed, the customer can contact Customer Service at 1-800-874-5178. Distributors are instructed to check their inventory for affected products and return them using an enclosed return label. Replacement product will be sent by the firm. Customer Service can be contacted at 1-800-874-5178. Accounts will be instructed to go to their inventory and look for the B006X641, -8.50 lot and open the secondary carton and verify the product inside. If it is the -9.00 product they can keep the product and re-slot it in the proper place within the kit (product is ok, nothing wrong with primary package or lens inside) and order a replacement -8.50 if necessary. Business reply cards will be supplied for accounts to return to third party indicating if they had any mix/mislabeled product.

Device

Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)
  • Modelo / Serial
    Lot B006X641
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.
  • Descripción del producto
    Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) || Mislabeled Outer (secondary) Label: Lot B006X641 || D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
  • Manufacturer
    Vistakon

Manufacturer

Vistakon
  • Dirección del fabricante
    Vistakon, 7500 Centurion Pkwy Ste 100, Jacksonville FL 32256-0517
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA