Events

Retiro De Equipo (Recall) de ACUVUE contact lens, extended-wear

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Vistakon 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
    22150
  • Fecha de inicio del evento
    2017-10-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Causa
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. 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.
  • Acción
    Product to be returned to supplier

Device

ACUVUE contact lens, extended-wear
  • Modelo / Serial
    Model: , Affected: ACUVUE OASYS 8.8 -04.50 6P
  • Manufacturer
    Vistakon Inc

Manufacturer

Vistakon Inc