Events

Retiro De Equipo (Recall) de Device Recall Coated BioEye Orbital Implant w/Conformer.

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 Integrated Orbital Implants 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
    58877
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2624-2011
  • Fecha de inicio del evento
    2011-05-20
  • Fecha de publicación del evento
    2011-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100459
  • 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
    Implant, eye sphere - Product Code hpz
  • Causa
    The recall was initiated because integrated orbital implants has confirmed certain lots of the coated bio-eye were manufactured without expiration dating visible on the packaging. all unlabeled product is currently beyond its expiration date.
  • Acción
    Integrated Orbital Implants Inc initiated a recall communication on 5/20/2011 with Integrated Orbital Implants (IOI) forwarding a Urgent Safety Notification letter to all their customers who had purchased the Coated Bio-Eye implants. The letter asked the customers to look for evidence of a printed expiration date on Coated Bio-eye package. If any Coated BioEye packages were not labeled with an expiration date the letter instructed customers to immediately sequester the products and not to use the products in surgery and contact IOI by telephone at (858) 6779990 or 1 (800) 4246537 to request an RMA number and shipping instructions. Also stated in the letter, IOI will replace Coated BioEye implants without expiration dates free of charge upon receipt of the implants labeled without expiration dates.

Device

Device Recall Coated BioEye Orbital Implant w/Conformer.
  • Modelo / Serial
    Lot/Unit Codes: 32764, 35906, 35907, 35908, 36307, 36308, 36309, 36315, 36316, 36364, 36430, 36431, 36469, 36470, 36471, 36476, 49216, 54304, 54569, 63449, 63450, 63710, 63803.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of nationwide and worldwide to: Japan, Greece, Germany, Romania, UAE, Australia, Canada, Philippines, Korea, Taiwan, Chile, Denmark, UK, Italy, Pakistan, Turkey, Philippines, India, South Africa, and Singapore.
  • Descripción del producto
    Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. || Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. || Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. || Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in || implant insertion and provides a means of securing muscles to the implant. || The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Dirección del fabricante
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
  • Source
    USFDA