Events

Rappel de Device Recall AMO WaveScan WaveFront System v3.65

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 VISX INCORPORATED, A SUBSIDIARY OF AMO 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
    47824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1695-2008
  • Date de mise en oeuvre de l'événement
    2006-11-17
  • Date de publication de l'événement
    2008-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70284
  • 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
    Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided lasik treatment at a facility in germany. the probability of a recurrence of this error was determined to be extremely remote. to ensure that this type of incident will not happen again, a software update was developed.
  • Action
    VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.

Device

Device Recall AMO WaveScan WaveFront System v3.65
  • Modèle / numéro de série
    All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
  • Description du dispositif
    Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
  • Manufacturer
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Manufacturer

VISX INCORPORATED, A SUBSIDIARY OF AMO INC
  • Adresse du fabricant
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC, 3400 Central Expy, Santa Clara CA 95051-0703
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA