Events

AlgerbrushII 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bausch & Lomb, 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
    75915
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0983-2017
  • 사례 시작날짜
    2016-10-12
  • 사례 출판 날짜
    2017-01-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151706
  • 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
    Burr, corneal, battery powered, rust ring removal - Product Code OHW
  • 원인
    According to firm ( bausch & lomb, inc. ) on june 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of sku 0816 c (pterygium burr medium diamond). further investigation found that repackaged algerbrush-ii and its accessories from april 30, 2012 to present, contained out of date operating instruction. therefore bausch & lomb is proposing a field correction to provide customer purchasing product from april 30, 2012 to june 20, 2016 with the current operating instruction.
  • 조치
    Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020

Device

AlgerbrushII
  • 모델명 / 제조번호(시리얼번호)
    LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s):  SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    Algerbrush-II || Product Usage: || Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
  • Manufacturer
    Bausch & Lomb, Inc.

Manufacturer

Bausch & Lomb, Inc.
  • 제조사 주소
    Bausch & Lomb, Inc., 1501 Graves Mill Rd, Lynchburg VA 24502-4328
  • 제조사 모회사 (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA