Events

Retiro De Equipo (Recall) de Biomedics Toric

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 Cooper Vision Caribbean Corp..

¿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
    69496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0529-2015
  • Fecha de inicio del evento
    2014-10-28
  • Fecha de publicación del evento
    2014-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130762
  • 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
    Lenses, soft contact, extended wear - Product Code LPM
  • Causa
    Portions of the lots may contain units with an incorrect lens axis condition.
  • Acción
    This recall is being initiated to the wholesale/distributor and Eye Care Practitioner level. Written communications will be forwarded to all first level consignees by overnight mailin..9. Receipt" tracking and follow up with consignees will be conducted according to the Effectiveness Check noted below. . - . The 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the product is unlikely to cause adverse health consequences. A user may notice blurred vision due¿ to the axis being out of specification but removal of the lens effectively reduces/eliminates any impairment. There is currently no indication that use of a lens with an Off Axis condition will create an injury requiring medical intervention. No permanent impairment is anticipated with or without medical intervention. Based on the analysis " described in the attached Health Hazard Evaluation, CooperVision will initiate a Class Ill recall. As noted by regulation, this classification is consistent with a situation in which use of, or exposure to, the product is unlikely .to cause adverse health consequences. Our evaluation of the Off Axis condition indicates it is unlikely to cause an adverse health reaction. Based on a Class Ill determination, the recall shall be conducted to the Wholesale level with a planned Effectiveness Check at Level B - 50% of Consignees to be contacted. Public Warning- in light of the low risk and proposed recall classification; a public warning is not warranted at this time. Distribution includes: " North America: Canada, USA " Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay, Venezuela, Mexico " Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden, Switzerland " Australia Returned lenses will be quarantined from distribution and destroyed as required. Actions and Dates: " Notify FDA through 806 Form on 10/23/14 " Initiate External communications starting 10/28/2014 " C

Device

Biomedics Toric
  • Modelo / Serial
    Lots # 8246525202 & 8255525096
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    Soft Contact Lens
  • Manufacturer
    Cooper Vision Caribbean Corp.

Manufacturer

Cooper Vision Caribbean Corp.
  • Dirección del fabricante
    Cooper Vision Caribbean Corp., 500 Road 584, Amuelas Industrial Park, Juana Diaz PR 00795
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA