Events

Rappel de Laser Loupes

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 Kerr 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
    63516
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0414-2013
  • Date de mise en oeuvre de l'événement
    2012-04-10
  • Date de publication de l'événement
    2012-11-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114115
  • 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
    Loupe, diagnostic/surgical - Product Code FSP
  • Cause
    The firm initiated the recall for laser loupes because the ink used to mark which laser frequency each laser loupe protects against may wipe off. the loupes work according to specification, but the marking may not permanently adhere to the device.
  • Action
    Customers were notified via USPS 1st class mail on April 10, 2012 to US and Canadian, and Rest of World (ROW) consignees, and on April 27, 2012 to European consignees. The notification letter identifies the product, reason for recall, and instructions to customers:"Please review the table below to verify that the laser loupes being used in your office has the correct filter color. ORASCOPTIC KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND FAXING BACK THE ENClOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS FIELD CORRECTION. If you are an authorized Orascoptic distributor, please inform your affected customers of this notification within forty-eight (48) hours of receipt.". Customer contact information was also provided:"Please contact Orascoptic Customer Care at 608.831.2555 or toll free in the United States and Canada at 1-800369- 3698 for more information.".

Device

Laser Loupes
  • Modèle / numéro de série
    The Laser Loupes are custom made-to-order products.   There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
  • Description du dispositif
    The brand name of the device is Laser Loupes, a dentalloupe || with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. || Laser Loupes are || available with four (4) different filters of different colors. Each colored filter is || associated with specific laser frequency ranges. The device listing number for this product is E160359. || The intended use of this device is to magnify the operatory field and provide laser eye protection.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Adresse du fabricant
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA