Events

Rappel de Lentis Foldable Intraocular Lenses (IOL)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01194-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01194-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer oculentis has identified possible sporadic opacification of the intraocular lens (iol). studies conducted for oculentis have indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the iol. although the cause of iol opacification is multifactorial, remnants could make the iol under certain conditions more prone to opacification. the opacification may compromise the optical transparency of the iol in time, potentially leading to a slow reduction in the patient's visual acuity.
  • Action
    1. For on-shelf units, users are to quarantine all affected stock, then complete and return the attached reply form fax to acknowledge receipt of this notice and advise your quantity of affected stock. 2. For implanted units there is no need for explanting or review of patients where the lens has been implanted. 3. In some cases, postoperative opacification of the IOL may present biomicroscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness. 4. IOL exchange is the only recommended treatment for postoperative opacification if the visual acuity is compromised in view of the patient's individual conditions and needs.

Device

Lentis Foldable Intraocular Lenses (IOL)
  • Modèle / numéro de série
    Lentis Foldable Intraocular Lenses (IOL)Model Numbers starting with L-, LU- and LS- Expiry: between 2017-01 and 2020-05ARTG Number: 198807
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd