Events

Device Recall Sovereign Compact Phacoemulsification System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Medical Optics, 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
    65292
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1670-2013
  • 사례 시작날짜
    2013-05-23
  • 사례 출판 날짜
    2013-07-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118560
  • 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
    Abbott medical optics inc. (amo) initiated this urgent notice of medical device correction and advisory notice to all customers who use the amo sovereign¿ compact phacoemulsification system, version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
  • 조치
    AMO issued an "Urgent Notice of Medical Device Correction and Advisory Notice" on May 23, 2013 via email, to all customers with a Sovereign¿ Compact Phacoemulsification System v 5.3 to inform them of the issue and provide them with actions to take in the event of sound loss during use of the Sovereign¿ Compact Phacoemulsification System, v 5.3.

Device

Device Recall Sovereign Compact Phacoemulsification System
  • 모델명 / 제조번호(시리얼번호)
    Product Name: Sovereign¿ Compact Console Universal, Part Number: CMP680300. The Sovereign¿ Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign¿ Compact systems manufactured at the Third Party Manufacturer, Sanmina-SCI Corporation, the serial number format is YYYY35XXX where Y is for the year manufactured and "35" designates manufacturing at Sanmina-SCI Corporation. The Sanmina-SCI Corporation started manufacturing the Sovereign¿ Compact v 5.3 systems in February 2012. For Sovereign¿ Compact systems manufactured at the AMO Manufacturing USA, LLC facility in Milpitas, CA the serial number format is YYYY80XXX where Y is for the year manufactured and "80" designates manufacturing at Milpitas. The Milpitas facility started manufacturing the v 5.3 systems in February 2013. The serial number is contained in the Product Identification Label (part number Z352548) that is attached to the rear of the console for systems manufactured.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
  • 제품 설명
    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
  • Manufacturer
    Abbott Medical Optics, Inc.

Manufacturer

Abbott Medical Optics, Inc.
  • 제조사 주소
    Abbott Medical Optics, Inc., 510 Cottonwood Dr, Milpitas CA 95035-7403
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA