Rappel de Device Recall Encore and OneVue

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Coopervision 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
    26532
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0978-03
  • Date de mise en oeuvre de l'événement
    2003-06-25
  • Date de publication de l'événement
    2003-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2005-04-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • Cause
    The actual sphere power of the lens is lower than the labeled value.
  • Action
    Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.

Device

  • Modèle / numéro de série
    There are 768 lot numbers as follows: 3669001157,  3669001465,  3669001756,  3669001960,  3669002711,  3669002714,  3669002816,  3669003208,  3669003214,  3669500011,  3669500414,  3669500514,  3779000756,  3779001722,  3779002117,  3779002513,  3779002911,  3779003020,  3779003624,  3779003906,  3779005316,  3779500013,  3779500120,  3890000722,  3890001706,  3891001712,  3892000954,  3892001402,  3892001414,  3892001712,  3893001417,  3893001611,  3893001711,  3893002612,  3893002613,  3893002712,  3893003020,  3893003107,  3893003302,  3893003614,  3893004706,  3893004806,  3893500111,  3893500702,  3893500802,  3893500902,  3894001058,  3894001560,  3894001654,  3894002213,  3894002607,  3894002610,  3894002811,  3894003005,  3894004306,  3894004502,  3894004904,  3894005004,  3894500205,  3894500310,  3894500311,  3894500313, 3894500402,  3894500411,  3894500511,  3894500704,  3894500706,  3895001456, 3895002758,  3895002855,  3895003024,  3895003220,  3895003315,  3895003320, 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
  • Description du dispositif
    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) || and (2) ONEVUE 55 toric (methafilcon A) flexible wear. || Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Coopervision Inc, 711 North Road, Scottsville NY 14643
  • Source
    USFDA