Events

Device Recall LaserEdge Knives 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bausch & Lomb Inc Irb 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
    76874
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0869-2018
  • 사례 시작날짜
    2017-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160000
  • 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
    Knife, ophthalmic - Product Code HNN
  • 원인
    The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, bausch + lomb is voluntarily recalling all product codes sku manufacturing without the electro-polish control and penetration force testing.
  • 조치
    On March 3, 2017 Bausch + Lomb , distributed Urgent Medical Device Recall notices and Acknowledgement Forms to customers via FedEx. Customers were advised to: 1. Please review your inventory and quarantine all unused (full and partial) boxes of LaserEdge" knives (6/Box or individual packaged knives) affected lots. 2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact Bausch + Lomb to obtain a Return Material Authorization Number (RMA) and arrange for a pickup of the identified product. You can contact the Bausch + Lomb Surgical Customer Service team by calling 1-800-338-2020, Customer Service (option 2), Product Returns and Adverse Event Reporting (option 2). Please contact the Bausch + Lomb Surgical Customer Service team with any questions or concerns regarding this process: 1-800-338-2020.

Device

Device Recall LaserEdge Knives
  • 모델명 / 제조번호(시리얼번호)
    none
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only || Product Usage: || The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
  • Manufacturer
    Bausch & Lomb Inc Irb

Manufacturer

Bausch & Lomb Inc Irb
  • 제조사 주소
    Bausch & Lomb Inc Irb, 1400 Goodman St N, Rochester NY 14609-3547
  • 제조사 모회사 (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA