Events

Rappel de Device Recall Laser Indirect Ophthalmoscope (LIO) .

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 Iridex Corporation.

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
    79386
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1075-2018
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162191
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Cause
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
  • Action
    Action Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672

Device

Device Recall Laser Indirect Ophthalmoscope (LIO) .
  • Modèle / numéro de série
    Device Identity : 87300, 87301, 87302, 87303, 87304
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
  • Description du dispositif
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) || The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
  • Manufacturer
    Iridex Corporation

Manufacturer

Iridex Corporation
  • Adresse du fabricant
    Iridex Corporation, 1212 Terra Bella Ave, Mountain View CA 94043-1824
  • Société-mère du fabricant (2017)
    Iridex Corporation
  • Source
    USFDA