Events

Rappel de Device Recall BioEye

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 Integrated Orbital Implants 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
    36298
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0012-2007
  • Date de mise en oeuvre de l'événement
    2006-02-27
  • Date de publication de l'événement
    2006-10-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48367
  • 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
    orbital implant - Product Code HPZ
  • Cause
    The end label on the outer box was mislabeled on 9 of a 10 unit lot. the end label says ''22 mm'' and the implants are actually ''20 mm''. the main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
  • Action
    The recall was to the distributor level. From contact with the two distributors involved, it was determined that all of the product affected was still with the two distributors. Both distributors affected were notified via email 2/27/2006. The correct labels were shipped by FEDEX to each of them. Both distributors were instructed to check their inventory of this lot number and confirm if the end labels were in conflict with the main outer box label. When this was confirmed, the distributor was instructed to apply the correct end labels supplied.

Device

Device Recall BioEye
  • Modèle / numéro de série
    Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Internationally to Finland & France
  • Description du dispositif
    Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Adresse du fabricant
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
  • Source
    USFDA