Events

Rappel de Alcon AcrySof IQ IOL with ULTRASERT Delivery System

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 Alcon Research, 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
    74824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2708-2016
  • Date de mise en oeuvre de l'événement
    2016-07-28
  • Date de publication de l'événement
    2016-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148530
  • 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 ultrasert delivery system from certain lots have an inferior surface characteristic that could result in the iol becoming lodged in the delivery system.
  • Action
    Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon.

Device

Alcon AcrySof IQ IOL with ULTRASERT Delivery System
  • Modèle / numéro de série
    Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***
  • Description du dispositif
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System || Product Usage: || The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • Adresse du fabricant
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    USFDA