Events

Rappel de Constellation Vision System

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 Research LTD dba Alcon Laboratories, 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
    55648
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1933-2010
  • Date de mise en oeuvre de l'événement
    2010-04-30
  • Date de publication de l'événement
    2010-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91452
  • 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
    unit, phacofragmentation - Product Code HQC
  • Cause
    Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
  • Action
    The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

Device

Constellation Vision System
  • Modèle / numéro de série
    All lot/serial numbers
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 || The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
  • Manufacturer
    Alcon Research LTD dba Alcon Laboratories, Inc.

Manufacturer

Alcon Research LTD dba Alcon Laboratories, Inc.
  • Adresse du fabricant
    Alcon Research LTD dba Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618-3818
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    USFDA