WaveLight FS 200 Femtosecond Laser System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wavelight AG 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58601
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2292-2011
  • 사례 시작날짜
    2011-04-18
  • 사례 출판 날짜
    2011-05-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    keratome, ac-powered - Product Code HNO
  • 원인
    The software calculating the patterns were found to has a rounding error for certain parameter ranges. these rounding errors could result in an incomplete cut in the donor or patient tissue.
  • 조치
    WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers to discontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3. Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.

Device

  • 모델명 / 제조번호(시리얼번호)
    Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.
  • 제품 설명
    WaveLight FS200 Femtosecond Laser System || Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2. || The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Wavelight AG, Industriegebiet Doellnitz 5, Pressath Germany
  • Source
    USFDA