Events

Retiro De Equipo (Recall) de Various Acuvue for Astigmatism Contact Lenses

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Pacific Pty Ltd.

¿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
    RC-2017-RN-01377-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-11-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01377-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Johnson & johnson vision care (jjvc) has identified quality issues identified with specific batches of acuvue contact lenses. a limited number of confirmed reports were received in relation to a foreign matter visible within the contact lens package and a lens being “off power”. foreign matter - a limited number of reports of a brush bristle found between the blister package and foil have been received.Off power - a limited number of confirmed reports of a lens being “off power” have been received, where a consumer may recognise as not accurately correcting the vision in one eye (some distortion or blurriness). not all lenses in these lots are affected and there is no significant health risk related to this issue.To date, there have been no adverse events related to these issues.
  • Acción
    Eye Care Professionals are advised to check stock and quarantine the affected lot numbers. Affected stock can be returned for unaffected product.

Device

Various Acuvue for Astigmatism Contact Lenses
  • Modelo / Serial
    Various Acuvue for Astigmatism Contact LensesAcuvue Oasys for Astigmatism, 8.6 -6.00 -1.75/170 6P and 8.6 -3.50 -0.75/180 6PLot Numbers: B00GW4Z and B00HRMGExpiry: Nov 2018 and Jul 2019Acuvue Oasys, 8.8 -04.00 6P RXLot: L002NCSExpiry: May 2020Acuvue Oasys, 8.8 -04.50 6PLot: L002QH9Expiry: Aug 20201 Day Acuvue Moist for Astigmatism, 8.5 -7.50 -1.25/180 90PLot: F00LF41Expiry: Apr 2021ARTG Numbers: 223534, 223535, 223536 and 154490
  • Manufacturer
    Johnson & Johnson Pacific Pty Ltd

Manufacturer

Johnson & Johnson Pacific Pty Ltd