Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Novartis Biociências S.A.; WAVELIGHT GMBH - ALEMANHA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1858
  • Fecha
    2016-03-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    ANVSANVISA