Events

Aqua-sense intraocular lens manufactured by Ophthalmic Innovations International Inc. (OII Inc.) distributed in the United Kingdom between December 1, 1999 and November 15, 2000. These lenses can be identified by serial numbers with order 00003-XXXX to 00313-XXXX. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 OPHTHALMIC INNOVATIONS INTERNATIONAL INC. 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
    777
  • 날짜
    2004-04-05
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    The latest notification by the manufacturer indicates that of the 868 lenses implanted in the United Kingdom, 233 (27%) were explanted due to opacification. The Medicines and Healthcare Products Regulatory Agency - MHRA has established direct communication with specialized professionals who agree to the actions listed above as being the most appropriate.
  • 원인
    Ophthalmic innovations international inc. (oii inc.) has issued a letter addressed to uk health professionals in may 2001 informing their clients of an increased incidence of opacification with the aqua-sense intraocular lens and recommending that monitor their patients in the postoperative period. while the cause of opacification is multi-factorial, studies conducted by the manufacturer indicate that surface calcification appears to be linked to the migration of silicone from the package onto the surface of the lens. no lens has been supplied to the uk since november 2000.
  • 조치
    1) Identify patients implanted with these lenses; 2) Consider contacts with these patients to alert them to a review visit if they are experiencing an opacified vision; 3) Ensure that all patients who have been implanted with affected lenses are aware that they must undergo a review visit if their vision deteriorates in the future; 4) Report all incidents of manufacturer-independent opaque intraocular lens to the Surveillance Unit - UTVIG / GGTPS / ANVISA and its lens manufacturer; 5) Watch out if the UTVIG Technovigilance Unit will publish further information on the Hydroviem IOL opacification incident.

Device

Aqua-sense intraocular lens manufactured by Ophthalmic Innovations International Inc. (OII Inc.) ...

Manufacturer

OPHTHALMIC INNOVATIONS INTERNATIONAL INC.
  • Source
    ANVSANVISA