Events

Retiro De Equipo (Recall) de Device Recall AMO brand WaveScan WaveFront System

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 AMO Manufacturing USA, LLC.

¿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
    56394
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1374-2011
  • Fecha de inicio del evento
    2010-07-13
  • Fecha de publicación del evento
    2011-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93449
  • 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
    Excimer laser system - Product Code LZS
  • Causa
    The failure to comply with minimum system requirements, increased system errors could result, and a miscreated treatment table (incorrect lasik refractive treatment) could result.
  • Acción
    Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to take the following actions: Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530. For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com. For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.

Device

Device Recall AMO brand WaveScan WaveFront System
  • Modelo / Serial
    All units of these Catalog Numbers. Part Number: 0070-1531, Catalog Numbers:  0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671  0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 nternational version
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.
  • Descripción del producto
    AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, || Part Number: 0070-1531, Catalog Numbers: || 0070-1664,0070-1649,0070-1654: Version 3.67 || 0070-1721: Version 3.671 || 0070-1662: Version 3.67, US version; || 0070-1668; IVersion 3.67 International version || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX¿ STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • Dirección del fabricante
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA