Events

Rappel de Device Recall Horizon

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 American Optisurgical 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
    52697
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1808-2009
  • Date de mise en oeuvre de l'événement
    2009-03-24
  • Date de publication de l'événement
    2009-09-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83671
  • 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
    phacoemulsification system - Product Code HQC
  • Cause
    Device operation interrupted: a software bug causes phaco to stop when vacuum goes above 300 mmhg while in multi burst mode. use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk.
  • Action
    American Optisurgery sent an E-mail to customers on April 2, 2009 stating the reason for recall and informed them to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, please identify customers and identify them at once of this product recall. Their notification to customers may be enhanced by including a copy of this recall notification letter. They were then told to refer to the enclosed Recall Questionnaire for instructions on what to do with the recalled product: The recall should be carried out to the user level and return the enclosed response form as soon as possible. If there are any questions, they are advised to contact David Salzberg at (800) 576-1266.

Device

Device Recall Horizon
  • Modèle / numéro de série
    Serial Numbers: 1114, 1116, 1118, 1120-1124, and 1126-1129.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (California), Brazil, Algeria, France, South Korea, India, and Peru.
  • Description du dispositif
    American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
  • Manufacturer
    American Optisurgical Inc

Manufacturer

American Optisurgical Inc
  • Adresse du fabricant
    American Optisurgical Inc, 25501 Arctic Ocean Dr, Lake Forest CA 92630
  • Société-mère du fabricant (2017)
    American Optisurgical Inc
  • Source
    USFDA