Events

Device Recall ACUVUE ADVANCE Brand Contact Lens 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Johnson & Johnson Vision Care, 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
    64468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1336-2013
  • 사례 시작날짜
    2012-12-21
  • 사례 출판 날짜
    2013-05-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116215
  • 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
    Limited number of individual contact lens packages may not have been completely sealed.
  • 조치
    The firm, Johnson & Johnson, Vision Care, Inc. sent a letter dated January 9, 2013 to all their consignees stating the following actions: " Please contact your patients that may have received any of the affected product and instruct them to discontinue use immediately and return product to you for replacement " Please return the enclosed Business Reply Card (BRCl confirming for our records that you have received this notice, and indicating whether or not you have in stock, or have distributed to patients, any product from the lots noted above. " Please return any remaining affected product in your possession using the enclosed pre-paid mailer. " Pass this notice on to anyone in your practice that needs to be informed " Customer service will arrange for the return and replacement of any affected product. If you have any questions and/or if replacement lenses are needed, please contact customer Service (1-800-87 4-5278).

Device

Device Recall ACUVUE ADVANCE Brand Contact Lens
  • 모델명 / 제조번호(시리얼번호)
    Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.
  • 제품 설명
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. || The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.
  • Manufacturer
    Johnson & Johnson Vision Care, Inc.

Manufacturer

Johnson & Johnson Vision Care, Inc.
  • 제조사 주소
    Johnson & Johnson Vision Care, Inc., 7500 Centurion Pkwy, Jacksonville FL 32256-0517
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA