Events

Retiro De Equipo (Recall) de TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AMO CANADA COMPANY.

¿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
    98332
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Amo is initiating this action due to detection of an inspection equipment malfunction that resulted in a total of 58 distributed lenses not being fully checked prior to release. it has been identified that this malfunction may result in the release of mislabelled intraocular lenses. use of a mislabelled intraocular lens could lead to potential unexpected postoperative refractive error and may result in a secondary surgical intervention. intraocular lenses with serial numbers included in the recall letter that have been implanted and resulted in an appropriate post-op refractive outcome are not affected by this action.

Device

TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: PCB00 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: AR40E (Lot serial: 2015871503); Model Catalog: ZXR00 (Lot serial: 8496921508); Model Catalog: ZCB00 (Lot serial: 5152641501); Model Catalog: ZCB00 (Lot serial: 5152541501); Model Catalog: ZCB00 (Lot serial: 5152621501); Model Catalog: ZCB00 (Lot serial: 5152481501); Model Catalog: ZCB00 (Lot serial: 5152561501); Model Catalog: ZCB00 (Lot serial: 5152601501); Model Catalog: ZCB00 (Lot serial: 5152501501); Model Catalog: ZCB00 (Lot serial: 5152461501); Model Catalog: ZCB00 (Lot serial: 5152581501); Model Catalog: ZCB00 (Lot serial: 5152661501)
  • Descripción del producto
    TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM;SENSAR FOLDABLE IOL WITH OPTIEDGE;TECNIS SYMFONY EXTENDED RANGE OF VISION IOL;TECNIS 1-PIECE ACRYLIC ASPHERIC IOL
  • Manufacturer
    AMO CANADA COMPANY

Manufacturer

AMO CANADA COMPANY
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Amo Canada Company
  • Source
    HC