Events

Rappel de Device Recall AMO brand WaveScan WaveFront 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 AMO Manufacturing USA, LLC.

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
    56394
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1374-2011
  • Date de mise en oeuvre de l'événement
    2010-07-13
  • Date de publication de l'événement
    2011-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93449
  • 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
    Excimer laser system - Product Code LZS
  • Cause
    The failure to comply with minimum system requirements, increased system errors could result, and a miscreated treatment table (incorrect lasik refractive treatment) could result.
  • Action
    Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to take the following actions: Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530. For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com. For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.

Device

Device Recall AMO brand WaveScan WaveFront System
  • Modèle / numéro de série
    All units of these Catalog Numbers. Part Number: 0070-1531, Catalog Numbers:  0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671  0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 nternational version
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.
  • Description du dispositif
    AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, || Part Number: 0070-1531, Catalog Numbers: || 0070-1664,0070-1649,0070-1654: Version 3.67 || 0070-1721: Version 3.671 || 0070-1662: Version 3.67, US version; || 0070-1668; IVersion 3.67 International version || Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA || The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX¿ STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • Adresse du fabricant
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA