Events

Rappel de ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON 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
    31258
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-10-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Johnson & johnson vision care inc. (jjvc) is voluntarily recalling in canada two lots of acuvue oasys for astigmatism contact lenses because of quality concerns. two lots of acuvue oasys for astigmatism contact lenses that are being recalled have been associated with a limited number of confirmed reports of visual acuity being 'off power' which the consumer may recognize as not accurately correcting the vision in one eye (some distortion or blurriness).Upon investigation it was determined that inserts within the mold used for manufacturing were damaged when making the front and back curve molds of the contact lens. jjvc has implemented improved inspection techniques for the identification of damaged inserts within the mold. to date no patient injuries related to this issue have been reported. no customer complaints related to this recall were reported in canada.

Device

ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS

Manufacturer

JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON INC.