Events

Retiro De Equipo (Recall) de Device Recall Alcon Ladarwave

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 Alcon Laboratories, 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
    26816
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1078-03
  • Fecha de inicio del evento
    2003-07-21
  • Fecha de publicación del evento
    2003-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28510
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.
  • Acción
    The firm mailed their 'Urgent Medical Device Safety Alert' letters to health care professtionals on July 21, 2003 along with a response form. The letter alerts the user to the problem and also how to assure that no erroneous data was saved. The letter also states that a Service Representative will be visiting to install a corrective software version 7.93. The version was completed at the start of the recall and service representative visits to install the software upgrade began approximately 7/22/03.

Device

Device Recall Alcon Ladarwave
  • Modelo / Serial
    Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z LWN1513Z LWN1522Z LWN1626Z LWN1629Z LWN1647Z LWN1748Z LWN1796Z LWN1805Z LWN1817Z LWN1820Z LWN1821Z LWN1822Z LWN1823Z LWN1843Z LWN1846Z LWN1944Z LWN1945Z LWN1946Z LWN1947Z LWN1949Z LWN1950Z LWN1952Z LWN1953Z LWN1954Z LWN1955Z LWN1956Z LWN1957Z LWN1958Z LWN1959Z LWN1961Z LWN2187Z LWN2188Z LWN2189Z LWN2190Z LWN2191Z LWN2192Z LWN2193Z LWN2194Z LWN2197Z LWN2198Z LWN2199Z LWN2200Z LWN2262Z LWN2263Z LWN2264Z LWN2265Z LWN2267Z LWN2268Z LWN2269Z LWN2270Z LWN2271Z LWN2272Z LWN2273Z LWN2276Z LWN2277Z LWN2278Z LWN2279Z LWN2280Z LWN2342Z LWN2343Z LWN2344Z LWN2345Z LWN2346Z LWN2347Z LWN2348Z LWN2349Z LWN2350Z LWN2351Z LWN2352Z LWN2353Z LWN2355Z LWN2356Z LWN2357Z LWN2403S LWN2404S LWN2405S LWN2406S LWN2414Z LWN2415Z LWN2416Z LWN2417Z LWN2420Z LWN2421Z LWN2427S LWN2428S LWN2464Z LWN2465Z LWN2466Z LWN2467Z LWN2468Z LWN2469Z LWN2470Z LWN2471Z LWN2472Z LWN2473Z LWN2475Z LWN2476Z LWN2477Z LWN2478Z LWN1609Z LWN1951Z
  • Clasificación del producto
    Ophthalmic Devices
  • Distribución
    109 U.S. customers and 48 international device locations. There were 12 devices on-hand.
  • Descripción del producto
    Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91
  • Manufacturer
    Alcon Laboratories, Inc.

Manufacturer

Alcon Laboratories, Inc.
  • Dirección del fabricante
    Alcon Laboratories, Inc., 2800 Discovery Dr., Orlando FL 32826
  • Source
    USFDA