Rayner acrylic intraocular lenses 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Rayner Intraocular Lenses Limited 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
    R1601-17
  • 사례 연번
    2014DM-0002413-R1
  • 날짜
    2016-01-14
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 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 reports that it has detected that internal quality tests have revealed that the products referenced and placed on the market may contain a residual level of an auxiliary polisher used in the manufacture of the medical device, above the normal limits, leading to potentially adverse events occurring on the patients.

Device

  • 모델명 / 제조번호(시리얼번호)
    C-flex Aspheric, Sulcoflex Aspheric, Sulcoflex Toric, Sulcoflex Aspheric and T-flex Aspheric ", specific serials.
  • 제품 설명
    SULCOFLEX lenses are contraindicated in patients in whom safe placement in the desired area can not be achieved. The absence of the peripheral capsule is safe, the lack of intact zonules, unusual oregular anatomy of the ciliary sulcus. Warnings: the unusual oregular anatomy of the ciliary sulcus can cause a postoperative regional displacement of the bundle. In such a case the mess can be realigned or fixed by suture. An iridiotomy or iridectomy may be necessary. Precautions and warnings: check the integrity of the sterile barrier system before deusing. Do not use if the barrier system is damaged. Do not sterilize. For sole use only. The single-use intraocular lens can not be used again since it is not designed to work as intended after the first and only use. Changes in mechanic, physical and chemical characteristics under conditions of repeated use, cleaning and resterilization will compromise the integrity of the intraocular lens.
  • Manufacturer

Manufacturer