Events

COMPLETE MoisturePLUS & COMPLETE Amino Moist 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Medical Optics, 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
    36711
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0344-2007
  • 사례 시작날짜
    2006-09-15
  • 사례 출판 날짜
    2007-03-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49201
  • 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
    contact lens solution - Product Code LPN
  • 원인
    Due to a potential sterility issue with the product container. three lots sold in japan were found to have bacterial contamination, which compromised sterility. because of this production-line issue at the firm's plant in china, amo is recalling lots that were manufactured on the same production lines during the same production period.
  • 조치
    Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

Device

COMPLETE MoisturePLUS & COMPLETE Amino Moist
  • 모델명 / 제조번호(시리얼번호)
    US Product Number 93184, Lot Numbers: ZB03087, ZB03724, ZB03734, ZB03735, ZB03736 & ZB03739 US Product Number 90104US, Lot Numbers: ZB02710, ZB02714, ZB02718 & ZB02722 US Product Number 90105US, Lot Numbers: ZB02746, ZB02750, ZB02771, ZB02792, ZB02796, ZB02800, ZB02704 & ZB03535
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
  • 제품 설명
    COMPLETE MoisturePLUS Multi-Purpose Solution || (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution || (Japan only)
  • Manufacturer
    Advanced Medical Optics, Inc.

Manufacturer

Advanced Medical Optics, Inc.
  • 제조사 주소
    Advanced Medical Optics, Inc., 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Source
    USFDA