Device Recall VisuMax Laser Keratome

  • Model / Serial
    P/N 1462-333, Size M, Lot # M130010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution: NV only.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Carl Zeiss Meditec AG, Carl Zeiss Promenade 10, Jena Germany
  • Manufacturer Parent Company (2017)
  • Source
    USFDA