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
  • 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
  • 1 Event

Fabricant

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