Events

Device Recall MONARCH II 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alcon Laboratories, 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
    49113
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2441-2008
  • 사례 시작날짜
    2008-07-07
  • 사례 출판 날짜
    2008-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72793
  • 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
    Cartridge - Product Code KYB
  • 원인
    Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.
  • 조치
    The recalling firm notified healthcare professional consignees and affiliated foreign distributors by letter on 07/07/08 and advised of the mislabeled device and potential hazard associated with delivery of the IOL. Consignees were instructed to return identified lots in their inventory and to return the enclosed business reply card for product replacement. Contact Stericycle Inc at 1-800-668-4391 for assistance with returning the recalled product. Contact Alcon Customer Service at 1-800-862-5266 for questions about the recall.

Device

Device Recall MONARCH II
  • 모델명 / 제조번호(시리얼번호)
    Lot 174249 Exp 07/2010 Lot 174250 Exp 07/2010 and  Lot 174244 Exp 07/2010
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and OUS: Brazil, Canada, Chile, Hong Kong, Singapore and India.
  • 제품 설명
    MONARCH¿ II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof¿ IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
  • Manufacturer
    Alcon Laboratories, Inc

Manufacturer

Alcon Laboratories, Inc
  • 제조사 주소
    Alcon Laboratories, Inc, 6201 South Fwy, Fort Worth TX 76134-2001
  • Source
    USFDA