Events

Constellation Vision System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Research LTD dba Alcon Laboratories, Inc. 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
    55648
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1929-2010
  • 사례 시작날짜
    2010-04-30
  • 사례 출판 날짜
    2010-07-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91448
  • 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
    unit, phacofragmentation - Product Code HQC
  • 원인
    Alcon identified system performance and machine settings that may impact the infusion performance of the constellation vision system, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
  • 조치
    The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.

Device

Constellation Vision System
  • 모델명 / 제조번호(시리얼번호)
    All lot/serial numbers
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution.
  • 제품 설명
    Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 || The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
  • Manufacturer
    Alcon Research LTD dba Alcon Laboratories, Inc.

Manufacturer

Alcon Research LTD dba Alcon Laboratories, Inc.
  • 제조사 주소
    Alcon Research LTD dba Alcon Laboratories, Inc., 15800 Alton Pkwy, Irvine CA 92618-3818
  • 제조사 모회사 (2017)
    Novartis Ag
  • Source
    USFDA