Device Recall VisuMax Laser Keratome

  • Modèle / numéro de série
    P/N 1462-333, Size M, Lot # M130010
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution: NV only.
  • Description du dispositif
    Treatment packs used on the VisuMax Laser Keratome. || Size M || Manufactured by Carl Zeiss Meditec AG, || Jena, Germany. || The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Carl Zeiss Meditec AG, Carl Zeiss Promenade 10, Jena Germany
  • Société-mère du fabricant (2017)
  • Source
    USFDA