Events

Rappel de EC3 Precision Aspheric Lens Intraocular Lens

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Aaren Scientific, Incorporated.

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
    60962
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1077-2012
  • Date de mise en oeuvre de l'événement
    2011-08-02
  • Date de publication de l'événement
    2012-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106906
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Intraocular lens - Product Code HQL
  • Cause
    The recall was initiated because aaren scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
  • Action
    Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.

Device

EC3 Precision Aspheric Lens Intraocular Lens
  • Modèle / numéro de série
    Lot Number: 110617
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
  • Description du dispositif
    Precision Aspheric Lens (PAL) Intraocular Lens || Model: EC-3 PAL, || Serial Number: 1169381106, 1169391106, 1169421106 || The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
  • Manufacturer
    Aaren Scientific, Incorporated

Manufacturer

Aaren Scientific, Incorporated
  • Adresse du fabricant
    Aaren Scientific, Incorporated, 4290 E Brickell St Ste A, Ontario CA 91761-1569
  • Société-mère du fabricant (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA