Events

Retiro De Equipo (Recall) de Device Recall LaserEdge Knives

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 Bausch & Lomb Inc Irb.

¿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
    76874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0886-2018
  • Fecha de inicio del evento
    2017-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160017
  • 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
    Knife, ophthalmic - Product Code HNN
  • Causa
    The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
  • Acción
    On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to: 1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2). Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.

Device

Device Recall LaserEdge Knives
  • Modelo / Serial
    none
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only || Product Usage: || The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
  • Manufacturer
    Bausch & Lomb Inc Irb

Manufacturer

Bausch & Lomb Inc Irb
  • Dirección del fabricante
    Bausch & Lomb Inc Irb, 1400 Goodman St N, Rochester NY 14609-3547
  • Empresa matriz del fabricante (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA