Device Recall Total Care (1) Contact Lens Solution 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Medical Optics Inc (AMO) 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
    56735
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0130-2011
  • 사례 시작날짜
    2010-07-23
  • 사례 출판 날짜
    2010-11-02
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Soft Lens Products Accessories - Product Code LPN
  • 원인
    The recall was initiated after amo determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
  • 조치
    AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: AH01257.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
  • 제품 설명
    AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). || Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705
  • 제조사 모회사 (2017)
  • Source
    USFDA