Events

Device Recall Sensar Foldable IOL with OptiEdge 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
    64015
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0929-2013
  • 사례 시작날짜
    2012-12-20
  • 사례 출판 날짜
    2013-03-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115219
  • 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
    Two production orders of these iols that contain mislabeled iols.
  • 조치
    AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.

Device

Device Recall Sensar Foldable IOL with OptiEdge
  • 모델명 / 제조번호(시리얼번호)
    Diopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207  Diopter 23.5  4759221207 4759821207 4760161207 4759231207 4759831207 4760171207 4759241207 4759841207 4760181207 4759251207 4759851207 4760191207 4759261207 4759861207 4760201207 4759271207 4759871207 4760211207 4759281207 4759881207 4760221207 4759291207 4759891207 4760231207 4759311207 4759901207 4760241207 4759321207 4759911207 4760251207 4759331207 4759921207 4759341207 4759931207 4759361207 4759941207 4759381207 4759951207 4759401207 4759961207 4759421207 4759971207 4759441207 4759981207 4759461207 4759991207 4759481207 4760001207 4759671207 4760011207 4759681207 4760021207 4759691207 4760031207 4759701207 4760041207 4759711207 4760051207 4759721207 4760061207 4759731207 4760071207 4759741207 4760081207 4759751207 4760091207 4759761207 4760101207 4759771207 4760111207 4759781207 4760121207 4759791207 4760131207 4759801207 4760141207 4759811207 4760151207
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
  • 제품 설명
    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, || Sensar Foldable IOL with OptiEdge || Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
  • 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