Events

HEALON Sterile Viscoelastic Solution 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Amo Uppsala Ab 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1705-183
  • 사례 연번
    2010DM-0006480
  • 날짜
    2017-05-19
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has detected the possible presence of glass particles from the cylinder due to damage in its opening, due to the introduction of incorrectly capped bottles into the packing station, which could potentially lead to the presentation of adverse events on patients or reoperations.

Device

HEALON Sterile Viscoelastic Solution
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    HEALON GV: indicated to maintain a deep anterior chamber during surgery, allowing efficient handling with greater protection of the corneal endothelium and other surrounding tissues. Use: due to its viscoelasticity it is used to maneuver and control weaves. HEALON: indicated to create and maintain a deep anterior chamber, allowing safe and controlled manipulation in the eye, reducing the risk of trauma to the corneal endothelium and other tissues. Use: it is used to handle, control and separate the tissues in an atraumatic way. HEALON 5: Indicated to create and maintain a deeper anterior chamber than the HEALON, it also creates and maintains a clear visual field during surgical intervention and allows a safe and controlled manipulation in the eye. Use: it is used to manage, control and separate the tissues in an atraumatic way. It can be used to push back an iris prolapse or a bulging vitreous body.
  • Manufacturer
    Amo Uppsala Ab

Manufacturer

Amo Uppsala Ab