Events

Rappel de Device Recall AMO TECHNIS CL

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-2864-2016
  • 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=149206
  • 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 AMO TECHNIS CL
  • Modèle / numéro de série
    Serial No. 1104621505 1164491602 1164501602 1164511602 1164521602 1164541602 1164551602 1164561602 1164571602 1164581602 1164601602 1164611602 1164621602 1164641602 1164651602 1164711602 1074911602 1074921602 1074931602 1074941602 1074951602 1074961602 1074971602 1074981602 1074991602 1075001602 1075011602 1075021602 1075031602 1075041602 1075051602 1075061602 1075071602 1075081602 1075091602 1075101602 1075111602 1075131602 1075141602 1075151602 1075121602
  • 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
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 || 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