Events

Rappel de Device Recall AquaRefresh

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 Marietta Vision.

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
    58008
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1557-2011
  • Date de mise en oeuvre de l'événement
    2011-02-21
  • Date de publication de l'événement
    2011-03-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97962
  • 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
    Accessories, soft lens products - Product Code LPN
  • Cause
    Product is misbranded; product labeled as, made in the netherlands, was actually manufactured in mexico.
  • Action
    John Patterson, President of Marietta Vision called each optical retailer on February 21, 2011, and told them of the misbranding issue in regards to country of origin. In addition, an Urgent Product Recall letter was sent to each account on February 23, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their AquaRefresh inventory for lot number KD005, and discontinue distribution of the samples immediately and to return any outstanding stock to Marietta Vision for exchange. Marietta Vision would return the misbranded product back to the Mexican factory at their expense to have the product packaging corrected. If they elect not to do so, Marietta Vision would have the product disposed of. Customers were instructed to fax the enclosed form back to Marietta Vision at 678-797-1099. For questions regarding this recall call 866-300-6257.

Device

Device Recall AquaRefresh
  • Modèle / numéro de série
    Lot Number: KD005
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AR, AZ, CA and TX.
  • Description du dispositif
    AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060. || Contact lens solutions used to clean, rinse, disinfect, rewet and store all soft contact lenses
  • Manufacturer
    Marietta Vision

Manufacturer

Marietta Vision
  • Adresse du fabricant
    Marietta Vision, 397 N Sessions St Nw, Marietta GA 30060-1325
  • Source
    USFDA