Device Recall MONARCH II

  • 모델명 / 제조번호(시리얼번호)
    Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA