Device Recall KAMRA INLAY

  • Modèle / numéro de série
    Lots A534-1014 and A535-1014
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
  • Société-mère du fabricant (2017)
  • Source
    USFDA