Events

Retiro De Equipo (Recall) de SofPort Advanced Optics Aspheric IOL

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bausch & Lomb Australia 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-00477-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-05
  • 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-00477-1
  • 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
    An investigation was initiated based on a limited number of complaints received for broken haptics during lens loading and insertion. this investigation resulted in bausch + lomb determining that a portion of a batch of haptic material is performing differently than other batches in terms of material elongation properties. a broken haptic during lens loading and insertion can result in surgical intervention (lens exchange) and increase the chance of damaging the eye. there have not been any reports of the haptic breaking after the surgery is complete.
  • Acción
    Customers are advised to segregate the affected IOLs and return them to their Bausch + Lomb (Australia) (B&L;) representative. The B&L; representative will arrange for the provision of replacement stock. If replacement product is needed for a scheduled surgery before the full return can be processed, please contact the B&L; representative to expedite shipment of the IOL. Surgeons are advised that if they have already implanted an affected IOL, there is no indication that the implanted IOL presents a health issue or performance concern. Therefore, patients should be followed as per their usual standard of care. All reports of broken haptics have occurred during lens loading or insertion. This could result in the need to exchange the lens during surgery. This action has been closed-out on 11/08/2016.

Device

SofPort Advanced Optics Aspheric IOL
  • Modelo / Serial
    SofPort Advanced Optics Aspheric IOL, Model LI61AOLI61AO 13.00MM 22.5Serial No.:4464602066Expiry Date: 31-Aug-19LI61AO 13.00MM 23.50Serial No.: 4464642033Expiry Date: 31-Aug-19ARTG No: 98915
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd