Events

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
    59980
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0276-2012
  • 사례 시작날짜
    2011-09-20
  • 사례 출판 날짜
    2011-11-23
  • 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=104241
  • 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
    The firm is initiating this voluntary recall because of the possibility that certain sensar iols are labeled with an incorrect diopter power.
  • 조치
    Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. For any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative. For any questions regarding this recall call 714-247-8656.

Device

Sensar Foldable IOL with OptiEdge
  • 모델명 / 제조번호(시리얼번호)
    5058981009 5059401009 5059831009  5058991009 5059411009 5059841009  5059001009 5059421009 5059851009  5059011009 5059431009 5059861009  5059021009 5059441009 5059871009  5059031009 5059451009 5059881009  5059041009 5059461009 5059891009  5059051009 5059471009 5059901009  5059061009 5059481009 5059911009  5059071009 5059491009 5059921009  5059081009 5059501009 5059931009  5059091009 5059511009 5059941009  5059101009 5059521009   5059111009 5059531009   5059121009 5059541009   5059131009 5059551009   5059141009 5059561009   5059151009 5059571009   5059161009 5059581009   5059171009 5059591009   5059181009 5059601009   5059191009 5059611009   5059201009 5059621009   5059211009 5059631009   5059221009 5059641009   5059231009 5059651009   5059241009 5059661009   5059251009 5059671009   5059261009 5059681009   5059271009 5059691009   5059281009 5059701009   5059291009 5059711009   5059301009 5059721009   5059311009 5059731009   5059321009 5059741009   5059331009 5059761009   5059341009 5059771009   5059351009 5059781009   5059361009 5059791009   5059371009 5059801009   5059381009 5059811009   5059391009 5059821009
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia
  • 제품 설명
    Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. || The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a 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