Events

Retiro De Equipo (Recall) de 1-DAY ACUVUE MOIST FOR ASTIGMATISM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON 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
    21522
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    One lot of acuvue advance and one lot of 1-day acuvue moist for astigmatism contact lenses are being recalled that have been associated with complaints of a foreign matter caught between the blister package and foil. upon completion of a root cause investigation the foreign matter was identified as a bristle of a brush used for periodic cleaning as part of the manufacturing process. a limited number of bristles from the brush came off during the cleaning process and were inadvertently sealed into the packaging of the product for these occurrences. no adverse events have been reported as the brush bristle in all instances has been visible to the consumer or customer when opening the contact lens blister package.

Device

1-DAY ACUVUE MOIST FOR ASTIGMATISM
  • Modelo / Serial
    Model Catalog: 1-DAY MOIST ASTIGMATISM (Lot serial: B00LF41); Model Catalog: ADVANCE WITH HYDRACLEAR (Lot serial: B00DHLP)
  • Descripción del producto
    1-DAY ACUVUE MOIST FOR ASTIGMATISM;ACUVUE ADVANCE WITH HYDRACLEAR CONTACT LENS
  • Manufacturer
    JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC