Device Recall Encore and OneVue 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Coopervision 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
    26532
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0978-03
  • 사례 시작날짜
    2003-06-25
  • 사례 출판 날짜
    2003-07-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2005-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Lenses, Soft Contact, Daily Wear - Product Code LPL
  • 원인
    The actual sphere power of the lens is lower than the labeled value.
  • 조치
    Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.

Device

  • 모델명 / 제조번호(시리얼번호)
    There are 768 lot numbers as follows: 3669001157,  3669001465,  3669001756,  3669001960,  3669002711,  3669002714,  3669002816,  3669003208,  3669003214,  3669500011,  3669500414,  3669500514,  3779000756,  3779001722,  3779002117,  3779002513,  3779002911,  3779003020,  3779003624,  3779003906,  3779005316,  3779500013,  3779500120,  3890000722,  3890001706,  3891001712,  3892000954,  3892001402,  3892001414,  3892001712,  3893001417,  3893001611,  3893001711,  3893002612,  3893002613,  3893002712,  3893003020,  3893003107,  3893003302,  3893003614,  3893004706,  3893004806,  3893500111,  3893500702,  3893500802,  3893500902,  3894001058,  3894001560,  3894001654,  3894002213,  3894002607,  3894002610,  3894002811,  3894003005,  3894004306,  3894004502,  3894004904,  3894005004,  3894500205,  3894500310,  3894500311,  3894500313, 3894500402,  3894500411,  3894500511,  3894500704,  3894500706,  3895001456, 3895002758,  3895002855,  3895003024,  3895003220,  3895003315,  3895003320, 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 9853002305,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
  • 제품 설명
    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) || and (2) ONEVUE 55 toric (methafilcon A) flexible wear. || Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Coopervision Inc, 711 North Road, Scottsville NY 14643
  • Source
    USFDA