Events

Device Recall COMPLETE Amino Moist MultiPurpose Solution 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
    38019
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1093-2007
  • 사례 시작날짜
    2007-05-25
  • 사례 출판 날짜
    2007-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53072
  • 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
    In response to information received 05/25/2007 from the u.S. centers for disease control and prevention (cdc) regarding eye infections from acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. cdc estimates a risk of at least seven times greater for those who use complete moistureplus solution versus those who did not.
  • 조치
    On Friday, May 25, 2007 at 11:16 ET, AMO issued a press release to the market related to the voluntary recall of AMO's COMPLETE MoisturePLUS TM Multi-Purpose Solution from the market. Similar press releases, specific to the geographic regions, were issued in the other markets beginning on Saturday, May 26, 2007. A copy of the United States press release is present on the AMO website (www.amo-inc.com) and was forwarded to the FDA for posting on the FDA web site. In addition, the FDA also completed a press release related to the AMO recall and it is available on the FDA web site. Regulatory agency notifications in all markets affected outside the United States were initiated beginning on Monday, May 28. Beginning on Thursday, May 31, AMO (via Stericycle) distributed RetaiI Customer notification packages via overnight UPS delivery to the 485 customer accounts in the United States.

Device

Device Recall COMPLETE Amino Moist MultiPurpose Solution
  • 모델명 / 제조번호(시리얼번호)
    All Lots (154 lots in Japan).    Each product is clearly identified with a lot number and expiration date, which is displayed on either the outer top or bottom panel of the unit carton and on two case labels on the case shipper. In addition, each bottle is clearly identified with a lot number and expiration date.  The first digit of the lot number denotes the identification of the AMO manufacturing site, Z = Hangzhou, China, A = Alcobendas, Spain.  The second digit denotes the year of manufacture (A= 2005, B = 2006, C = 2007) per AMO Standard Operating Procedure.  The third through the seventh digits denote the sequential number of production orders produced in either the Hangzhou, China or Alcobendas, Spain facility in that year, starting with 00001. Note that several product lines use this lot numbering system in each facility, so the sequential numbering is not unique to any specific product or formulation.  As an example, ZB01234, the lot number represents the 1,234th production order initiated in the Hangzhou, China facility in 2006.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Canada, Europe, Japan, China and various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines).
  • 제품 설명
    COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers:93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA
  • 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