Events

Retiro De Equipo (Recall) de Hydrophilic Acrylic Single Use lntraocular Lens system packs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kevin Grundy (IBD) Pty Ltd.

¿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
    RC-2015-RN-00180-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-03-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00180-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Rayner through kevin grundy (ibd) pty ltd is informing the customers that certain products released to market contain an injector (individually wrapped within the product carton) that has a slightly shorter expiry date than the expiry date as shown on the outer carton. the affected lots may have an expiry date (on the outer carton) of november 2019, december 2019 or january 2020), the individually wrapped injector has its own expiry date marked on the tyvek lid. the expiry date of the associated injectors is around one month prior to that shown on the outer carton.There is no immediate issue associated with the use of the product. the affected product will not expire at least for four year and eight months.
  • Acción
    Kevin Grundy (IBD) Pty Ltd (for Rayner) is requesting the customers to return all the affected units. Rayner Intraocular Lenses Limited offers free replacementfor the products that are not intended to be used in the short term.

Device

Hydrophilic Acrylic Single Use lntraocular Lens system packs
  • Modelo / Serial
    Hydrophilic Acrylic Single Use lntraocular Lens system packsProduct Model No.: 623TBatch Numbers: 65190, 64525, 64529, 64720, 65224,65224, 65251, 65544 ARTG Number 100926Product Model No.: 653LBatch Number:65122ARTG Number:1752621
  • Manufacturer
    Kevin Grundy (IBD) Pty Ltd

Manufacturer

Kevin Grundy (IBD) Pty Ltd