Events

Rappel de Device Recall TECNIS 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 AMO Puerto Rico Manufacturing, Inc..

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
    68346
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2280-2014
  • Date de mise en oeuvre de l'événement
    2014-05-13
  • Date de publication de l'événement
    2014-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128864
  • 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
    Units may be labeled with the incorrect diopter power.
  • Action
    AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.

Device

Device Recall TECNIS CL
  • Modèle / numéro de série
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
  • Description du dispositif
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. || Product Usage: || AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
  • Manufacturer
    AMO Puerto Rico Manufacturing, Inc.

Manufacturer

AMO Puerto Rico Manufacturing, Inc.
  • Adresse du fabricant
    AMO Puerto Rico Manufacturing, Inc., Rd # 402, Km 4.2, Anasco PR 00610
  • Source
    USFDA