Events

Retiro De Equipo (Recall) de LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials 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 Device Technologies 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-2014-RN-01322-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-18
  • 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-2014-RN-01322-1
  • 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
    The manufacturer has received sporadic notifications of postoperative opacification of the lentis hydrosmart inta ocular lenses (iol’s) in glass vials of all implanted hydrosmart iol’s since 2006. analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the iol material and the fluctuating, batch related presence of silicone residues on some iol’s. such residues may potentially change the iol surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. these deposits may compromise the optical transparency of the iol, potentially leading to a reduction in the patient’s visual acuity.
  • Acción
    Customers are requested to inspect their stock and quarantine any affected units in preparation for return to Device Technologies. Surgeons are advised that if postoperative opacification is observed to evaluate visual acuity levels and consider surgical IOL replacement if visual acuity is compromised in face of the patient’s individual conditions and needs. Intraocular lens replacement is the only recommended treatment for postoperative calcification of the IOL leading to compromise of visual acuity. In some cases postoperative opacification of the IOL may present bio- microscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness and avoid YAG laser capsulotomy in patients with an opacificied IOL since this procedure may affect the IOL replacement if needed in the future. Please see http://www.tga.gov.au/alert/lentis-hydrosmart-intraocular-lenses-supplied-glass-vials . This action has been closed-out on 4/08/2016.

Device

LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials IOL
  • Modelo / Serial
    LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials IOL Model Numbers: All starting with L-, LU-, or LS- Serial Numbers: All starting with 20000 ARTG Number: 192478(All Oculentis IOL models packaged in a blister are not affected by this recall action.)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd