Device Recall SoFlex SE Foldable Intraocular Lens

  • 모델명 / 제조번호(시리얼번호)
    Model Number: LI61SE, Lot Number: 4916928.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.
  • 제품 설명
    Bausch & Lomb SoFlex SE Foldable Intraocular Lens. || UPC 4001404, Rx Only, STERILE. || Manufactured by: || Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. || Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA