Events

Retiro De Equipo (Recall) de Laser Loupes

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Kerr Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63516
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0414-2013
  • Fecha de inicio del evento
    2012-04-10
  • Fecha de publicación del evento
    2012-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114115
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Loupe, diagnostic/surgical - Product Code FSP
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
  • Descripción del producto
    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
  • Dirección del fabricante
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA