Events

Retiro De Equipo (Recall) de Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boucher & Muir 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-2013-RN-01262-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-06
  • 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-2013-RN-01262-1
  • 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
    Inspections findings by the fda noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. no injuries have been reported for viscocel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
  • Acción
    Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.

Device

Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL
  • Modelo / Serial
    Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mLProduct Codes: AusVIS15, AusVIS20Batch Numbers: 13D02 (expiry 04/2015), 12A13 (expiry 01/2015), 12J08 (expiry 10/2014), 13B18 (expiry 02/2015), 12J02 (expiry 10/2014), 12G16 (expiry 07/2014), 12I04 (expiry 09/2014) and 12H20 (expiry 08/2014)Manufactured from September 01, 2011 to September 19, 2013ARTG Number: 132648
  • Clasificación del producto
    Ophthalmic Devices
  • Manufacturer
    Boucher & Muir Pty Ltd

Manufacturer

Boucher & Muir Pty Ltd