Events

Alerte De Sécurité sur Product name: Ophthalmic equipment Ophthalmic equipment Registration number ANVISA: 80625080019 Hazard class: II Affected model: AL-Scan Affected serial numbers: 140001; 140002; 140003; 140004; 140005; 140006; 140007; 140008; 140009; 140010; 140011; 140012; 140013; 140014; 140015; 140016; 140017; 140018; 140019; 140020; 140021; 140022; 140023; 240001; 240002; 240003; 240004; 240005; 240006; 240007; 240008; 240009; 240010; 240011; 240012; 240013; 240014; 240015; 240018; 240019; 240020; 240021; 240022; 240023; 240024; 240025; 240026; 240027; 240028; 240029; 240030; 240031; 240032; 240033; 240034; 240035; 240037; 240038; 240039; 240040; 240041; 240042; 240043; 240044; 240045; 240046; 240047; 240048; 240049; 240050; 240051; 240052; 240053; 240054; 240055; 240056; 240058; 240059; 240060; 240061; 240062; 240063; 240064; 240065; 240066; 240067; 240068; 240069; 240070; 240071; 240072; 240073; 240074; 240075; 240076; 240077; 240078; 240079; 240080; 240081; 240082; 240083; 240084.

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 NIDEK EYECARE DO BRASIL COMERCIO DE INSTRUMENTOS OPTICOS LTDA; NIDEK CO. LTD.

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
    2166
  • Date
    2016-10-21
  • 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
    For safe use, the manufacturer recalls the importance of measuring the axial length with the eye model when connecting the product, according to the AL-Scan user's manual. If any of the following occur, re-measure the axial length with the eye model after restarting the AL-Scan and making sure the graphing waveform is correct. * When strong static electricity occurs around the product. * When recognizing graphical wave disorder due to noise through axial length data.
  • Cause
    The manufacturer was informed by some overseas customers (there were no cases in brazil) regarding the unusual axial length display due to possible external electromagnetic interference under abnormal operating conditions. then the manufacturer decided to send a letter to users to clarify that the al-scan equipment complies with the international standard iec60601-1-2: 2007 for electromagnetic compatibility of medical devices and has been found to operate correctly under normal operating conditions. in this letter, nidek emphasizes, as a preventive measure, the importance of consulting the user's manual regarding the emc (electromagnetic compatibility) that defines the normal electromagnetic operating conditions. in addition, the manufacturer emphasizes that, for safety reasons, the axial length measurement is done with the eye model (device to verify the accuracy of the measurement) when connecting the equipment according to the instructions described in the al user's manual -scan.
  • Action
    Field Action Code AC001 triggered under the responsibility of the company NIDEK EYECARE DO BRASIL COMERCIO DE INSTRUMENTOS OPTICOS LTDA. Company will make correction in the field.

Device

Product name: Ophthalmic equipment Ophthalmic equipment Registration number ANVISA: 80625080019 H...

Manufacturer

NIDEK EYECARE DO BRASIL COMERCIO DE INSTRUMENTOS OPTICOS LTDA; NIDEK CO. LTD
  • Source
    ANVSANVISA