Events

Retiro De Equipo (Recall) de HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Designs for Vision Aust 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-2013-RN-00164-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-22
  • 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-2013-RN-00164-1
  • 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
    This recall/hazard alert is being undertaken following higher than expected reported rates of inflammation and/or endophthalmitis from doctors using ny-60, isert 250, and isert 251 iols in a few countries. an extensive review of the manufacturing process by hoya revealed that some products had trace residual foreign particulates on them.
  • Acción
    Please quarantine and return all the affected stock to Designs For vision Pty Ltd. For any patient already implanted with one of the lenses included in this recall. For any patient already implanted with one of the lenses included in this recall, Hoya is recommending follow-up with the patient at three (3) and six (6) months post-operatively to monitor for the possible onset of ocular inflammation. Patients should be reviewed earlier, or as needed, if symptomatic. For more details, please see http://www.tga.gov.au/safety/alerts-device-hoya-intraocular-lenses-130403.htm#consumers .

Device

HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311),...
  • Modelo / Serial
    HOYA One-Piece Intraocular Lenses (IOL) Models : HOYA AF-1 iMICS1 (NY-60), HOYA AF-1 Toric (311), HOYA iSert (250 and 251), HOYA iSert Toric (351)Affected Serial numbers ranges:KULX0011 - KUMZ0TN2)JKLX0012 - JKN10CE4JLLX0012 - JLN116T6PNLX0012 - PNMZ04Q8PPLX0011 - PPMZ01C8PQLX0021 - PQMZ00E7PRLX0011 - PRMZ00R6PSLX0012 - PSMZ0078PTLX0011 - PTMZ0048PULX0011 - PUMZ00E8PALY0011 - PAM200S6PBLY0011 - PBM200C8PCLY0011 - PCM200N8ARTG: 117417
  • Manufacturer
    Designs for Vision Aust Pty Ltd

Manufacturer

Designs for Vision Aust Pty Ltd