Device Recall OPTICAL BIOMETER

  • Modèle / numéro de série
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
  • Description du dispositif
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. || Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Société-mère du fabricant (2017)
  • Source
    USFDA