Device Recall Proclear 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
    66844
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0542-2014
  • 사례 시작날짜
    2013-11-20
  • 사례 출판 날짜
    2013-12-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-22
  • 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
    Lens, contact, (disposable) - Product Code MVN
  • 원인
    Lots were labeled with incorrect expiration dates on secondary package (carton). the primary package (blister) is marked with the correct expiration date.
  • 조치
    CooperVision sent an Urgent Medical Device Recall Letters dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Our records indicate you received some of the affected product. Enclosed you will find a list of affected carton lot numbers, with the correct expiration date, that were shipped to your account. " Please immediately examine your inventory, " Stop any further distribution of carton(s) subject to the recall, " Quarantine carton(s) with incorrect expiration date, and " CooperVision will make arrangements to remove affected, quarantine product. As soon as possible, please complete the attached response form and fax it to 1.866.484.1048 or scan and email to info@coopervision.com. If you have product to return please contact customer service for instructions and to schedule pick-up and removal of affected, quarantined product. Your account will be credited once the product is returned and processed. We appreciate your assistance and apologize for any inconvenience you or your patients experienced by this removal. If you have any further questions, please feel free to contact us at 800-341-2020.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 361950571720, potential incorrect expiry date 1/2018;  Lot 361950575934, potential incorrect expiry date 9/2017;  Lot 361950589008, potential incorrect expiry date 2/2018;  Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017;  Lot 361950608721, potential incorrect expiry date 6/2018;  Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018;  Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017, potential incorrect expiry date 3/2017; Lot 361950863106, potential incorrect expiry date 9/2017; Lot 361950894913, potential incorrect expiry date 1/2018; Lot 361950912828, potential incorrect expiry date 6/2018; Lot 361950919611, potential incorrect expiry date 4/2018; Lot 361950919914, potential incorrect expiry date 4/2018; Lot 361950937619, potential incorrect expiry date 5/2018; Lot 361950955510, potential incorrect expiry date 7/2013, 8/2018; Lot 361950955610, potential incorrect expiry date 3/2018;  Lot 361950971611, potential incorrect expiry date 4/2018; Lot 361950972311, potential incorrect expiry date 8/2018, 8/2013; Lot 361951007612, potential incorrect expiry date 7/2017;  Lot 361951028930, potential incorrect expiry date 2/2018; Lot 361951041224, potential incorrect expiry date 2/2018; Lot 361951053705, potential incorrect expiry date 7/2018; Lot 361951057108, potential incorrect expiry date 7/2018.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
  • 제품 설명
    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA || daily use disposable contact lenses
  • Manufacturer

Manufacturer

  • 제조사 주소
    CooperVision Inc., 180 Thruway Park Dr, W Henrietta NY 14586-9798
  • 제조사 모회사 (2017)
  • Source
    USFDA