Events

Device Recall Private Eyes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Contact Lens Store, 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
    29281
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1313-04
  • 사례 시작날짜
    2004-06-07
  • 사례 출판 날짜
    2004-08-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33462
  • 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
    The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
  • 조치
    Consignees were first contacted by telephone with a f/u letter sent 6/7/2004

Device

Device Recall Private Eyes
  • 모델명 / 제조번호(시리얼번호)
    Unknown. The firm failed to establish a lot numbering system for the theatrical contact lenses. The majority of the vials in stock at the firm have lot number BB43.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    MA, TX, WA.
  • 제품 설명
    Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Manufactured by Soft Lens Technology, Lot BB43 Expiration Date 08/06, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire..
  • Manufacturer
    The Contact Lens Store, Inc.

Manufacturer

The Contact Lens Store, Inc.
  • 제조사 주소
    The Contact Lens Store, Inc., 638 Church Street, Marietta GA 30060
  • Source
    USFDA