Events

Rappel de ACUVUE contact lens, extended-wear

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 Vistakon Inc.

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
    22150
  • Date de mise en oeuvre de l'événement
    2017-10-27
  • 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: Johnson & Johnson (New Zealand) Limited, 507 Mt. Wellington Highway, Mt. Wellington, Auckland 1060
  • Cause
    Off power:, two lots of acuvue® oasys for astigmatism were found to be off power for optical correction of refractive error. the consumer may recognise this issue as the contact lens is not accurately correcting the vision in one eye (some distortion or blurriness)., foreign matter, two lots of acuvue® oasys® contact lenses were found to contain a brush bristle between the blister package and foil. no adverse events have been reported as the brush bristle in all instances, has been visible to the consumer or customer when opening the contact lens blister package.
  • Action
    Product to be returned to supplier

Device

ACUVUE contact lens, extended-wear
  • Modèle / numéro de série
    Model: , Affected: ACUVUE OASYS 8.8 -04.50 6P
  • Manufacturer
    Vistakon Inc

Manufacturer

Vistakon Inc