Device Recall KAMRA INLAY

  • 모델명 / 제조번호(시리얼번호)
    Lots A534-1014 and A535-1014
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
  • 제품 설명
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 || (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AcuFocus, Inc., 32 Discovery Ste 200, Irvine CA 92618-3161
  • 제조사 모회사 (2017)
  • Source
    USFDA