Events

Device Recall Laser Indirect Ophthalmoscope (LIO) . 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Iridex Corporation 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
    79386
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1075-2018
  • 사례 시작날짜
    2018-02-27
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162191
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns.
  • 조치
    Action Taken by IRIDEX: 1. A investigation was started immediately upon receipt of the returned devices from the Sloan Kettering complaint on November 3, 2017. CAPA 0125 was initiated to document the events, root cause, correction, corrective and preventive action and effectiveness of these actions. 2. A ship hold was initiated on November 15, 2017. 3.As described below, IRIDEX plans to notify customers and distributors that it is voluntarily recalling all models of the TruFocus LIO Premiere. 4. Public Warning A press release was prepared and sent out on February 23, 2018. For further questions please call (650) 962-8848 Ext. 3672

Device

Device Recall Laser Indirect Ophthalmoscope (LIO) .
  • 모델명 / 제조번호(시리얼번호)
    Device Identity : 87300, 87301, 87302, 87303, 87304
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Distribution and to the countries of : China, Germany, Australia, Canada, Ireland, Lebanon, Japan, Israel and Qatar
  • 제품 설명
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) || The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.
  • Manufacturer
    Iridex Corporation

Manufacturer

Iridex Corporation
  • 제조사 주소
    Iridex Corporation, 1212 Terra Bella Ave, Mountain View CA 94043-1824
  • 제조사 모회사 (2017)
    Iridex Corporation
  • Source
    USFDA