Events

Device Recall Glitter Eyes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ciba Vision Corporation 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
    25796
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0703-03
  • 사례 시작날짜
    2003-03-17
  • 사례 출판 날짜
    2003-04-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-04-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26487
  • 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 lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
  • 조치
    The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.

Device

Device Recall Glitter Eyes
  • 모델명 / 제조번호(시리얼번호)
    Green, PID Lot#NA, Button Lot#22940-32, Blue, PID Lot#40523337, Button Lot#22940-32, Bronze, PID Lot#40538359, Button Lot#22940-32, Violet, PID Lot#40522198, Button Lot #22940-32, Green, PID Lot#40581596, Button Lot#22985-95, Blue PID Lot 40550786, Button Lot#22620-19, Blue PID Lot#40505677, Button Lot#22620-20, Bronze PID Lot#40540880, Button Lot#22620-19, Violet, PID Lot#40543810, Button Lot#22620-19.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada and Puerto Rico.
  • 제품 설명
    Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
  • Manufacturer
    Ciba Vision Corporation

Manufacturer

Ciba Vision Corporation
  • 제조사 주소
    Ciba Vision Corporation, 11440 Johns Creek Parkway, Duluth GA 30097
  • Source
    USFDA