Events

Retiro De Equipo (Recall) de T-FLEX TORIC HYDROPHILIC ACRYLIC LENS INJECTION SYSTEM PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RAYNER INTRAOCULAR LENSES LIMITED.

¿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
    16713
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-01-07
  • 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
    Internal quality checks have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (iols). rayner maintains extremely high levels of product quality and has set stringent internal limits for residual aluminium oxide levels. there is a possibility that certain products released to market may contain levels that slightly exceed these limits.

Device

T-FLEX TORIC HYDROPHILIC ACRYLIC LENS INJECTION SYSTEM PACK

Manufacturer

RAYNER INTRAOCULAR LENSES LIMITED