Events

Retiro De Equipo (Recall) de Device Recall TECNIS

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 Abbott Medical Optics Inc. (AMO).

¿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
    75051
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2856-2016
  • Fecha de inicio del evento
    2016-08-26
  • Fecha de publicación del evento
    2016-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149194
  • 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
    intraocular lens - Product Code HQL
  • Causa
    Abbott medical optics is recalling intraocular lenses (iols) because they were not being checked prior to release and this may result in the release of mislabeled iols.
  • Acción
    Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.

Device

Device Recall TECNIS
  • Modelo / Serial
    ZKB00 Serial No. 8667461602  8667751602 8667471602  8667761602 8667481602  8667771602 8667491602  8667781602 8667501602  8667801602 8667511602  8667811602 8667521602  8667821602 8667531602  8667831602 8667541602  8667841602 8667551602  8667851602 8667561602  8667861602 8667571602  8667871602 8667581602  8667881602 8667591602  8667891602 8667601602  8667901602 8667611602  8667911602 8667621602  8667921602 8667631602  8667931602 8667641602  8667961602 8667661602  8667971602 8667671602  8667981602 8667681602  8667991602 8667691602  8668001602 8667701602  8668011602    ZLB00 Serial No. 8960421506 8960431506 8960441506 8960451506 8960461506 8960471506 8960481506 8960501506 8960511506 8960531506 8960541506 8960581506 8960591506 8960621506 8960631506 8960641506 8960651506 8960661506 8960671506 8960681506 8960691506 8960701506 8960711506 8960721506 8960731506 8960741506
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
  • Descripción del producto
    TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; || The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
  • Manufacturer
    Abbott Medical Optics Inc. (AMO)

Manufacturer

Abbott Medical Optics Inc. (AMO)
  • Dirección del fabricante
    Abbott Medical Optics Inc. (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA