Events

Rappel 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)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Designs for Vision Aust Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00164-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00164-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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),...
  • Modèle / numéro de série
    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