Events

Retiro De Equipo (Recall) de Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case

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 Volk Optical Inc.

¿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
    73213
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1177-2016
  • Fecha de inicio del evento
    2016-02-02
  • Fecha de publicación del evento
    2016-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143579
  • 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
    Lens, contact, polymethylmethacrylate, diagnostic - Product Code HJK
  • Causa
    The firm discovered that the incorrect lot number was engraved on the product.
  • Acción
    Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.

Device

Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case
  • Modelo / Serial
    Model #: VG4SNF, Lot: BE05200
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
  • Descripción del producto
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 || for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
  • Manufacturer
    Volk Optical Inc

Manufacturer

Volk Optical Inc
  • Dirección del fabricante
    Volk Optical Inc, 7893 Enterprise Dr, Mentor OH 44060-5309
  • Empresa matriz del fabricante (2017)
    Halma Plc
  • Source
    USFDA