Events

Rappel de SofPort Advanced Optics Aspheric 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 Bausch & Lomb 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-2015-RN-00477-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • 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-2015-RN-00477-1
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
    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