Device Recall AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design

  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.
  • 제품 설명
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. || Indicated for primary implantation for the visual correction of aphakia in adult patients.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    AMO Puerto Rico Manufacturing, Inc., Rd # 402, Km 4.2, Anasco PR 00610
  • Source
    USFDA