Events

Constellation Vision System Pneumatic Handpiece 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Grieshaber 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
    65006
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1506-2013
  • 사례 시작날짜
    2013-04-17
  • 사례 출판 날짜
    2013-06-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117654
  • 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
    Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
  • 원인
    Alcon is conducting a medical device removal for the constellation pneumatic handpiece, dsp, product number 725.01. this action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the directions for use.
  • 조치
    Alcon sent an "URGENT: MEDICAL DEVICE REMOVAL" letter on April 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Alcon Sales Representative for questions regarding this notice.

Device

Constellation Vision System Pneumatic Handpiece
  • 모델명 / 제조번호(시리얼번호)
    All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turkistan, Venezuela, and Veit Nam.
  • 제품 설명
    The Constellation Vision System Pneumatic Handpiece. || Indicated for both anterior and posterior segment opthalmic surgery.
  • Manufacturer
    Alcon Grieshaber AG

Manufacturer

Alcon Grieshaber AG
  • 제조사 주소
    Alcon Grieshaber AG, Winkelriedstrasse 52, Schaffhausen Switzerland
  • 제조사 모회사 (2017)
    Novartis Ag
  • Source
    USFDA