Events

Alcon MONARCH III C Cartridge 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Research, Ltd. 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
    75049
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0978-2017
  • 사례 시작날짜
    2016-09-05
  • 사례 출판 날짜
    2017-01-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149191
  • 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
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • 원인
    The intraocular lens could become lodged within the cartridge.
  • 조치
    Alcon sent an Urgent Field Safety Action letter dated August 2016 to all affected consignees who received the affected product. Customers were instructed to check their inventory and segregate any of the affected cartridges. Customers were also asked to complete and return the Product Recall Response Form. , requesting the return of any units in their inventory. If customers had transferred product to other organizations, they were asked to provide them with a copy of the notice. Customers with questions were instructed to contact Alcon. For questions regarding this recall call 817-551-3058.

Device

Alcon MONARCH III C Cartridge
  • 모델명 / 제조번호(시리얼번호)
    Alcon Monarch II C Cartridge Model 8065977762, Lot Number 32395407, Manufacture Date 8/13/2015
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to Mexico only
  • 제품 설명
    Alcon Monarch III (1) "C" Cartridge || The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
  • Manufacturer
    Alcon Research, Ltd.

Manufacturer

Alcon Research, Ltd.
  • 제조사 주소
    Alcon Research, Ltd., 6201 South Fwy, Fort Worth TX 76134-2099
  • 제조사 모회사 (2017)
    Novartis Ag
  • Source
    USFDA