Events

Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The See Clear Company 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
    76279
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1404-2017
  • 사례 시작날짜
    2017-01-06
  • 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=152629
  • 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
    Sterility and misbranding: lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
  • 조치
    The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.

Device

Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear
  • 모델명 / 제조번호(시리얼번호)
    All lots of lenses sold between 10/31/2013 to 10/31/2016
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and country of: Canada.
  • 제품 설명
    Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
  • Manufacturer
    The See Clear Company

Manufacturer

The See Clear Company
  • 제조사 주소
    The See Clear Company, 4995 Buford Hwy Ste 102, Peachtree Corners GA 30071-2721
  • Source
    USFDA