Devices

Device Recall MONARCH II

  • Modèle / numéro de série
    Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
  • Description du dispositif
    MONARCH¿ II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof¿ IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
  • Manufacturer
    Alcon Laboratories, Inc
  • 1 Event

Fabricant

Alcon Laboratories, Inc
  • Adresse du fabricant
    Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA