Events

ACRYLIC LENS TECNIS 1 PART MODEL ZCB00. Registro Anvisa 80147060093. Products affected: products with the following expiration dates 05/2011, 06/2011, 07/2011, 08/2011, 09/2011 and 10/2011. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Vistatek Produtos Óticos S/A.; Abbott Medical Optics 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
    998
  • 날짜
    2009-11-23
  • 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
    According to information presented by the product registration holder, the lens problem was caused by a recent change in the production process, which has already been corrected to avoid further problems. The recall in question only affects Tecnis Model ZCB00 lenses with the expiration dates quoted in this alert (see Product Description field). Anvisa's Technovigilance Unit is monitoring this case.
  • 원인
    Possibility of the handles adhering to the lens, after insertion into the patient's eye. this situation may lead to further manipulation during surgery, which may involve injury to the patient's eye.
  • 조치
    The company Vistatek Produtos Óticos S / A (holder of the product registration in Brazil) has already begun issuing notification letters to the customers who purchased the affected lots. The actions recommended to health professionals are as follows: (1) Verify in your inventory the existence of affected products (see affected lots in the Product Description field); (2) If a product is found, segregate it, identifying it properly so that it is not inadvertently used; (3) Communicate the company (see Source Description field) by means of a specific form (available at www.xxxxx); (4) Send the problem product (s) to Vistatek S / A. If you work with this product but do not have the batches affected in your inventory, fill out the form anyway and send, stating that you do not have the batches affected.

Device

ACRYLIC LENS TECNIS 1 PART MODEL ZCB00. Registro Anvisa 80147060093. Products affected: products ...

Manufacturer

Vistatek Produtos Óticos S/A.; Abbott Medical Optics Inc.
  • Source
    ANVSANVISA