Events

Rappel de 1-DAY ACUVUE MOIST FOR ASTIGMATISM

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
    21522
  • Classe de risque de l'événement
    II
  • 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
    One lot of acuvue advance and one lot of 1-day acuvue moist for astigmatism contact lenses are being recalled that have been associated with complaints of a foreign matter caught between the blister package and foil. upon completion of a root cause investigation the foreign matter was identified as a bristle of a brush used for periodic cleaning as part of the manufacturing process. a limited number of bristles from the brush came off during the cleaning process and were inadvertently sealed into the packaging of the product for these occurrences. 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.

Device

1-DAY ACUVUE MOIST FOR ASTIGMATISM
  • Modèle / numéro de série
    Model Catalog: 1-DAY MOIST ASTIGMATISM (Lot serial: B00LF41); Model Catalog: ADVANCE WITH HYDRACLEAR (Lot serial: B00DHLP)
  • Description du dispositif
    1-DAY ACUVUE MOIST FOR ASTIGMATISM;ACUVUE ADVANCE WITH HYDRACLEAR CONTACT LENS
  • Manufacturer
    JOHNSON & JOHNSON VISION CARE DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

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