Events

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR 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
    79152
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1210-2018
  • 사례 시작날짜
    2017-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162501
  • 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
    Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
  • 조치
    On October 19, 2017, Johnson and Johnson sent letters to their customers stating the recall of ACUVUE and given the instructions to review their inventory, stop using the affected lots, use the enclosed label to return any affected products, contact customer service to arrange the return, even if they do not have any recall product inventory. A contact was provided to each individual letter.

Device

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
  • 모델명 / 제조번호(시리얼번호)
    Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J; Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J; Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
  • 제품 설명
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
  • 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