Events

Device Recall TECNIS 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
    75051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2859-2016
  • 사례 시작날짜
    2016-08-26
  • 사례 출판 날짜
    2016-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149200
  • 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
    intraocular lens - Product Code HQL
  • 원인
    Abbott medical optics is recalling intraocular lenses (iols) because they were not being checked prior to release and this may result in the release of mislabeled iols.
  • 조치
    Abbott Medical Optics, Inc. sent an Urgent Field Safety Notice to all affected customers to inform them that Abbott Medical Optics (AMO) is recalling 737 IOLs due to detection of an inspection equipment malfunction that resulted in a total of 737 distributed lenses not being fully checked prior to release. The letter informs customers that this malfunction may result in the release of mislabeled IOLs. The letter informs the customers of the actions to be taken. Customers are instructed to complete Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com. Customers with any questions related to the IOL return process are instructed to contact an AMO Customer Service Representative at 877-266-4543. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543.

Device

Device Recall TECNIS
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 2624401411 2624411411 2624421411 2624431411 2624441411 2624451411 2624461411 2624471411 2624481411 2624491411 2624501411 2624511411 2624521411 2624531411 2624541411 2624551411 2624561411 2624571411 2624581411 2624591411 2624601411 2624611411 2624621411 2624631411 2624641411 2624651411 2624661411 2624671411 2624681411 2624691411 2624701411 2624711411 5259101407 5259111407 5259121407 5259131407 5259141407 5259151407 5259161407 5259171407 5259181407 5259191407 5259201407 5259211407 5259221407 5259231407 5259241407 5259251407 5259261407 5259271407 5259281407 5259291407 5259301407 5259311407 5259321407 5259331407 5259341407 5259351407 5259361407 5259371407 5259381407 5259391407 5259401407 5259411407 5259421407 5259431407 5259441407 5259451407 5259461407 5259471407 5259481407 5259491407 5259501407 5259511407 5259521407 5259531407 5259541407 5259551407 5259561407 5259571407 5259581407 5259591407 5259601407 5259611407 5259621407 5259631407 5259641407 5259651407 5259661407 5259671407 5259681407 5259691407 5259701407 5259711407 5259721407 5259731407 5259741407 5259751407 5259761407 5259771407 5259781407 5259791407 5259801407 5259811407 5259821407 5259831407 5259841407 5259851407 5259861407 5259871407 5259881407 5259891407 5259901407 5259911407 5259921407 5259931407 5259941407 5259951407 5259961407 5259971407 5259981407 5259991407 5260001407 5260011407 5260021407 5260031407 5260041407 5260051407 5260061407 5260071407 5260081407
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
  • 제품 설명
    TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V || The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
  • Manufacturer
    Abbott Medical Optics Inc. (AMO)

Manufacturer

Abbott Medical Optics Inc. (AMO)
  • 제조사 주소
    Abbott Medical Optics Inc. (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA