Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Novartis Biociências S.A.; WAVELIGHT GMBH - ALEMANHA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1858
  • Date
    2016-03-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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
  • Société-mère du fabricant (2017)
    Novartis Ag
  • Source
    ANVSANVISA