Events

Device Recall 1Day Acuvue Moist contact lenses for Astigmatism 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
    60810
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0734-2012
  • 사례 시작날짜
    2011-12-01
  • 사례 출판 날짜
    2012-01-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106522
  • 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
    Lens, contact, (disposable) - Product Code MVN
  • 원인
    Johnson & johnson vision care, inc. recalled their 1-day acuvue moist brand contact lenses for astigmatism due to a lot being mixed. the secondary carton lot number and power are not the same as on the primary package inside the carton.
  • 조치
    The firm, Johnson & Johnson Vision Care, sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated 1 December 2011 to all consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their practice/store inventory for product affected by this discrepancy in labeling; if you dispensed this product to a patient; contact the patient and replace lenses to all intended visual correction and performance with the correct lens power; complete and return ACKNOWLEDGEMENT OF RECEIPT Form via fax to: 904-443-3442 or email: VPIWEB@visus.jn.com and return any cartons labeled with the noted lot number to Customer Relations. Johnson & Johnson will replace them with the correct product. For any questions regarding this labeling situation, contact Customer Relations at 1-800-843-2020.

Device

Device Recall 1Day Acuvue Moist contact lenses for Astigmatism
  • 모델명 / 제조번호(시리얼번호)
    External carton Lot Number B00BVTN -1.50 -1.25cyl. 100¿ (30 primary packages per secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80¿ (30 primary packages per secondary carton)
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: NY and FL and countries of: Finland, France, Germany, Italy, Netherlands, Norway, Denmark, Switzerland, Sweden, and the United Kingdom.
  • 제품 설명
    Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" || Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" || It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
  • 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