Devices

Device Recall Monarc

  • Modelo / Serial
    Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.
  • Descripción del producto
    Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
  • Manufacturer
    American Medical Systems
  • 1 Event

Fabricante

American Medical Systems
  • Dirección del fabricante
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall MONARCH II
  • Modelo / Serial
    Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
  • Descripción del producto
    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