Events

Trade Name: VERION - REFERENCE UNIT; registration 80153480148; risk class II; List of lots / series existing in Brazil: 01102; 01690; 01693; 01695; 01699; 01710; 01722; 01840; 01841; 01843; 01844; 01847; 01863; 01875; 01876; 01887; 01890; 01897; 01898; 01899; 01901; 02013; 02014; 02015; 02017; 02024; 02025; 02026; 02027; 02028; 02029; 02030; 02032; 02034; 02035; 02036; 02037; 02276; 02282; 02288; 02295; 02296; 02298; 02307; 02310; 02311; 02315 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Novartis Biociências S.A.; WAVELIGHT GMBH - ALEMANHA 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
    1858
  • 날짜
    2016-03-15
  • 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
    Recommendations for Patients and Patients: The following actions apply only to surgical planning for non-Alcon manufactured intraocular lenses: NO REFERENCE UNIT (Surgical Planner): • Click on the 'IOL 100% - RI 0% 'immediately before exporting the surgical planning, creating the PDF or printing; • Review the saved .pdf and the surgical impression created. No arcuate incision should be visible; • If the arched incision is inadvertently added to the surgical planning, reopen the folder, click the 'IOL 100% - RI 0%' slider bar and export the surgical planning again, create a new PDF and surgical planning printout. In DIGITAL MARKER (DML): • Review the surgical planning shown in DIGITAL MARKER (DML) so that no arcuate incision is visible; • If the arched incision is visible, return to the REFERENCE UNIT (Surgical Planner), reopen the folder, and export the surgical planning again. No special action applies to surgical schedules for Alcon-made intraocular lenses and non-toric intraocular lenses not manufactured by Alcon. These unintended bowel incisions added to the surgical planning occur only with non-Alcon manufactured intraocular lenses. Alcon will install a software update on all VERION-REFERENCE UNITS (Vision Scanners) that are shared with the LenSx® Laser System to eliminate the possibility of unintentional addition of arcuate incisions in the surgical planning. Software update will be performed by an Alcon representative.
  • 원인
    The manufacturer is conducting a voluntary medical device correction of all verion - reference unit (surgical planner) (ms-80153480148), which are shared with the lensx® laser system (ms-80153480158), after receiving reports regarding the inclusion of unplanned arcuate incisions in printed, saved (.Pdf) or exported surgical plans. this situation occurs only when the verion-reference unit (surgical planner) is used to create a surgical plan for non-alcon-manufactured ocular intraocular lenses that are used with the lensx® laser system. surgical schedules for alcon-made intraocular lenses and non-alco non-ocular intraocular lenses are not affected. if the user involuntarily activates the sliding bar and additional unplanted arcuate incisions are performed, according to the exported surgical planning using digital marker (ms-80153480166), a hypercorrection of astigmatism may occur, causing reduction of visual acuity.
  • 조치
    Action code AG # 8468. Notification letter sent to clients /// Software update development /// Installation of the new software update, after approval of ANVISA. The start is expected to occur immediately after approval of the software update at ANVISA and the deadline for completing the updates on the equipment is 7 months.

Device

Trade Name: VERION - REFERENCE UNIT; registration 80153480148; risk class II; List of lots / seri...

Manufacturer

Novartis Biociências S.A.; WAVELIGHT GMBH - ALEMANHA