Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Novartis Biociências S.A.; WAVELIGHT GMBH - ALEMANHA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1858
  • Date
    2016-03-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    ANVSANVISA