Events

Rappel de Oculentis LENTIS HydroSmart foldable intraocular lens

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Oculentis GmbH.

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
    17876
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Cause
    Oculentis gmbh has received sporadic notifications of postoperative opacification of the lentis® hydrosmart iols in glass vials, resulting in a reported occurrence rate of 0.011% of all implanted hydrosmart iols since 2006., analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the iol material and the fluctuating, batch related presence of silicone residues on some iols. such residues may potentially change the iol surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. these deposits may compromise the optical transparency of the iol, potentially leading to a reduction in the patient's visual acuity.
  • Action
    Product to be returned to supplier

Device

Oculentis LENTIS HydroSmart foldable intraocular lens
  • Modèle / numéro de série
    Model: All IOL models starting with L-, LU-, or LS-, Affected: Serial numbers starting with 20000
  • Manufacturer
    Oculentis GmbH

Manufacturer

Oculentis GmbH