Events

Rappel de Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)

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 Vistakon.

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
    56460
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2445-2010
  • Date de mise en oeuvre de l'événement
    2010-07-16
  • Date de publication de l'événement
    2010-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93722
  • 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, extended wear - Product Code LPM
  • Cause
    Acuvue oasys brand contact lenses for astigmatism may be mislabeled on the outer (secondary) packaging carton. the outer (secondary) cartons labeled as lot b006x641 -8.50d -1.25cyl. 100 axis may actually contain primary packages from lot b006wbs1 -9.00d -1.25cyl. 80 axis. the inner (primary) package labeling is correct. product was only distributed to eye care professionals for use in proper f.
  • Action
    Vistakon issued an Important Product Notification dated July 28, 2010 to customers identifying the affected product, the labeling issue, and actions to be taken by the customer. Vistakon issued a separate Important Product Notification dated July 28, 2010 to distribuitors identifying the affected product, the labeling issue, and actions to be taken by the distributor. Customers are instructed to check their inventory for affected products and return a business reply card. If replacement -8.50 lenses are needed, the customer can contact Customer Service at 1-800-874-5178. Distributors are instructed to check their inventory for affected products and return them using an enclosed return label. Replacement product will be sent by the firm. Customer Service can be contacted at 1-800-874-5178. Accounts will be instructed to go to their inventory and look for the B006X641, -8.50 lot and open the secondary carton and verify the product inside. If it is the -9.00 product they can keep the product and re-slot it in the proper place within the kit (product is ok, nothing wrong with primary package or lens inside) and order a replacement -8.50 if necessary. Business reply cards will be supplied for accounts to return to third party indicating if they had any mix/mislabeled product.

Device

Device Recall ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A)
  • Modèle / numéro de série
    Lot B006X641
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA including all states, District of Columbia and Puerto Rico, and the countries of Canada, Bahamas, Honduras, and United Arab Emirates.
  • Description du dispositif
    Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 CYL 80 , 2013/05 AXIS. (Correct labeling) || Mislabeled Outer (secondary) Label: Lot B006X641 || D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose.
  • Manufacturer
    Vistakon

Manufacturer

Vistakon
  • Adresse du fabricant
    Vistakon, 7500 Centurion Pkwy Ste 100, Jacksonville FL 32256-0517
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA