Devices

Device Recall KAMRA INLAY

  • Modelo / Serial
    Lots A534-1014 and A535-1014
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
  • Descripción del producto
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 || (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
  • Manufacturer
    AcuFocus, Inc.
  • 1 Event

Fabricante

AcuFocus, Inc.
  • Dirección del fabricante
    AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
  • Empresa matriz del fabricante (2017)
    AcuFocus Inc.
  • Source
    USFDA