Events

Retiro De Equipo (Recall) de ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

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
    31258
  • Clase de Riesgo del Evento
    III
  • 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
    Johnson & johnson vision care inc. (jjvc) is voluntarily recalling in canada two lots of acuvue oasys for astigmatism contact lenses because of quality concerns. two lots of acuvue oasys for astigmatism contact lenses that are being recalled have been associated with a limited number of confirmed reports of visual acuity being 'off power' which the consumer may recognize as not accurately correcting the vision in one eye (some distortion or blurriness).Upon investigation it was determined that inserts within the mold used for manufacturing were damaged when making the front and back curve molds of the contact lens. jjvc has implemented improved inspection techniques for the identification of damaged inserts within the mold. to date no patient injuries related to this issue have been reported. no customer complaints related to this recall were reported in canada.

Device

ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

Manufacturer

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