Alcon Research, LTD.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 4 건

  • 모델명 / 제조번호(시리얼번호)
    1) 23G TotalPLUS Pak: Accurus Standalone - 8065750828, 2) 23G Combined Pack 0.9mm: Accurus Standalone - 8065750814, 3) 23G Combined Pack 1.1mm: Accurus Standalone - 8065750816, 4)23G TotalPLUS Pak: Constellation Standalone - 8065751058, 5) 23G Combined Pack 0.9mm: Constellation Standalone -8065751077, 6) 23G Combined Pack 1.1mm: Constellation Standalone - 8065751065. 7) 23G Small Parts Kit - 8065750842. Complete list of lot numbers will be provided with recall recommendation.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Greece, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria.
  • 제품 설명
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. || Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.
  • 모델명 / 제조번호(시리얼번호)
    2033459H, 2034186H, 2034491H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    States in the US - WI, NY, MO
  • 제품 설명
    Alcon Custom Pak
  • 모델명 / 제조번호(시리얼번호)
    Lot 507492, 507664, 507539
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
  • 제품 설명
    Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) || Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
  • 모델명 / 제조번호(시리얼번호)
    2060953H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution : Argentina Australia France Italy Mexico Poland Spain Sweden Russia South Korea Ukraine
  • 제품 설명
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak || Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Alcon Research, Ltd., 6201 South Freeway, Fort Worth TX 76134-2099
  • Source
    USFDA