Events

Retiro De Equipo (Recall) de INTRALASE FS Laser

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
    60241
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0167-2012
  • Fecha de inicio del evento
    2011-10-12
  • Fecha de publicación del evento
    2011-11-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104855
  • 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
    Keratome, ac-powered - Product Code HNO
  • Causa
    The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.G. 300 ¿m or deeper) created using the laser system.
  • Acción
    Abbott Medical Optics Inc. (AMO) issued an "ADVISORY NOTICE" letter dated October 12, 2011 to all affected customers. The letter identifies the affected products, the problem, and the actions needed to be taken. Customers were instructed to exercise caution when making cuts that approach the corneal endothelium. The letter includes a 1-page Operator's Manual addendum that clarifies the recommendations. The letter states that AMO will conduct a field correction to adjust the EOF on the affected FS Laser Systems. The letter includes a response form to be completed and returned as per the instructions. Customers were instructed to notify all appropriate staff/personnel of the Advisory Notice. For any further questions regarding the information or recommendations, contact an AMO representative at 1-800-266-3375

Device

INTRALASE FS Laser
  • Modelo / Serial
    All units of these models (models 2, 3 and iFS) except model 1.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
  • 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