Device Recall iSert Intraocular Lens (Model PC60AD)

  • Modelo / Serial
    This recall pertains to all serial numbers of I-ISO Model FC-60AD & PC-60AD lenses shipped to the U.S. and affected by this recall. A list of all affected serial numbers will be provided to the FDA LA District office. The total number of products on recall are 7355 different serial numbers on a excel spread sheet that will be attached when the Recall recommendation is sent to CDRH.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    iSert Intraocular Lens (Model PC-60AD)
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Hoya Surgical Optics, Inc., 14768 Pipeline Ave, Chino Hills CA 91709-3594
  • Empresa matriz del fabricante (2017)
  • Source