Devices

Device Recall Monarc

  • Model / Serial
    Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.
  • Product Description
    Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
  • Manufacturer
    American Medical Systems
  • 1 Event

Manufacturer

American Medical Systems
  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA

One device with a similar name

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Device Recall MONARCH II
  • Model / Serial
    Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
  • Product Description
    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