Events

Device Recall STAR S4 IR Excimer Laser System; Software Version 5.18 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AMO Manufacturing USA, LLC 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
    59330
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2971-2011
  • 사례 시작날짜
    2011-07-18
  • 사례 출판 날짜
    2011-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102306
  • 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
    Excimer laser system - Product Code LZS
  • 원인
    Reports of lower success rates with iris registration (ir) image capture with the star s4 ir excimer laser system v 5.3 that with previous version.
  • 조치
    Abbott Medical Optics (AMO) sent an "ADVISORY NOTICE" dated July 18, 2011 to all customers using the AMO WAVESCAN Wavefront System. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to create a separate patient file for each eye on the WAVESCAN System (STAR S4 IR Excimer Laser Systems,software versions 5.00-5.30) according to the directions in attachment A. Additionally, customers are to complete and return an attached form to AMO via fax at the regional fax number. Contact an AMO representative for questions regarding this notice.

Device

Device Recall STAR S4 IR Excimer Laser System; Software Version 5.18
  • 모델명 / 제조번호(시리얼번호)
    Model # 0030-4817
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.
  • 제품 설명
    STAR S4 IR Excimer Laser System; Software Version 5.18 || Mfg by : AMO Manufacturing USA, LLC || 510 Cottonwood Drive || Milpitas, CA 95035 || Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.
  • Manufacturer
    AMO Manufacturing USA, LLC

Manufacturer

AMO Manufacturing USA, LLC
  • 제조사 주소
    AMO Manufacturing USA, LLC, 510 Cottonwood Dr, Milpitas CA 95035-7403
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA