Events

Rappel de Device Recall TECNIS

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 Abbott Medical Optics Inc. (AMO).

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
    75051
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2858-2016
  • Date de mise en oeuvre de l'événement
    2016-08-26
  • Date de publication de l'événement
    2016-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149199
  • 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
    Abbott medical optics is recalling intraocular lenses (iols) because they were not being checked prior to release and this may result in the release of mislabeled iols.
  • Action
    Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.

Device

Device Recall TECNIS
  • Modèle / numéro de série
    Serial No. 2005271506 5914601206 4651021512 5807371506 4427981206 4427991206 4428001206 4428011206 4428021206 4428031206 4428041206 4428051206 4428061206 4428071206 4428081206 4428091206 4428101206 4428111206 4428121206 4428131206 4428141206 4428151206 4428161206 4428171206 4428181206 4428191206 4428201206 4428211206 4428221206 4428231206 4428241206 4428251206 4428261206 4428271206 4428281206 4428291206 4428311206 4428321206 4428331206 4428341206 4428351206 4428361206 4428371206 4428381206 5152461501 5152471501 5152481501 5152491501 5152501501 5152531501 5152541501 5152551501 5152561501 5152571501 5152581501 5152591501 5152601501 5152611501 5152621501 5152631501 5152641501 5152651501 5152661501 5152671501 4428301206
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
  • Description du dispositif
    TECNIS 1-Piece IOL, Model No. ZCB00 || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
  • Manufacturer
    Abbott Medical Optics Inc. (AMO)

Manufacturer

Abbott Medical Optics Inc. (AMO)
  • Adresse du fabricant
    Abbott Medical Optics Inc. (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA