Events

Centurion Vision System Technical Name: Centurion Vision System Registration Number ANVISA: 80153480089 Hazard Class: III Model Affected: Pack FMS Active, Basic (accessory); Pack FMS Active, 0.9mm Intrepid * Ultra ABS * Intrepid * Balanced 45º Serial numbers affected: 1799232H; 1794157H; 1801725H 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Novartis Biociência.; Alcon Laboratories, 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
    2102
  • 날짜
    2016-05-23
  • 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
    1. Review your inventory to determine if you have any affected lot units. 2. Immediately interrupt the use of affected units 3.Separe these affected products to ensure they will not be used 4. Alcon will contact you to arrange replacement of affected units if necessary 5.Please complete the form annex "Response Form", even if your facility does not have any units in stock. 6. Return the completed form to Alcon by e-mail: cs.brasil@alcon.com
  • 원인
    Alcon is conducting this voluntary withdrawal of medical device for specific batches of the fms active, basic pack and fms active pack, 0.9 mm intreoud ultra abs intrepid balanced 45 ° due to a possible presence of irregularity in the molding of the suction connector, which may result in reduction of vacuum in the suction line. the use of products from the affected batches of pack fms active, basic and pack fms active, 0.9 mm intrepid ultra abs * intrepid * balanced 45 ° can result in a small air leak and consequently a reduction in vacuum performance, leading to to an inability to achieve the maximum vacuum level and a reduction of the retention force at the distal end of the phaco tip.
  • 조치
    Field Action Code AG # 8500 triggered under the responsibility of the company Novartis Biociência. Company will collect for further destruction of the product.

Device

Centurion Vision System Technical Name: Centurion Vision System Registration Number ANVISA: 80153...

Manufacturer

Novartis Biociência.; Alcon Laboratories, inc.