Events

Rappel de Device Recall LADAR6000

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 Alcon Refractive Horizons, 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
    37605
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0854-2007
  • Date de mise en oeuvre de l'événement
    2007-02-21
  • Date de publication de l'événement
    2007-06-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51005
  • 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
    Excimer Laser System - Product Code LZS
  • Cause
    Observed 'central islands' in patients following custom myopia laser procedures using the ladar6000 excimer laser. (on may 11, 2007, alcon notified consignees that the device software programs for customcornea myopia and customcornea myopia with astigmatism of the device would be deactivated).
  • Action
    Consignees were notified of the recall via two letters. On Feb. 21, 2007, consignees were requested to immediately stop performing all custom cornea myopia procedures and to return an acknowledgement card indicating they have received the alert and understand the required actions. On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated. After meeting with CDRH's Office of Compliance on August 27, 2007, the recalling firm committed to total product removal of the device. Notification will begin in Sept 2007 and will be made by personal visits to each consignee.

Device

Device Recall LADAR6000
  • Modèle / numéro de série
    All serial/lot numbers of the LADAR6000
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-including USA, Czech Republic, Spain, Australia, Italy, Hong Kong, Vietnam, Singapore, South Korea, and Canada
  • Description du dispositif
    LADAR6000 Excimer Laser System
  • Manufacturer
    Alcon Refractive Horizons, Inc.

Manufacturer

Alcon Refractive Horizons, Inc.
  • Adresse du fabricant
    Alcon Refractive Horizons, Inc., 2800 Discovery Dr, Orlando FL 32826-3010
  • Source
    USFDA