Events

Alerta De Seguridad para Lentis Intraocular Lens

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por Oculentis BV.

¿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
  • Número del evento
    2017-288
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/471802-fda-advisory-no-2017-288
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2017-288 voluntary product recall of all lentis intraocular lens with expiry date between 2017-01 and 2020-05 all concerned healthcare professionals and establishments are hereby advised by the food and drug administration (fda) regarding the voluntary product recall of all lentis intraocular lens (iol) having an expiry date between 2017-01 and 2020-05 (see photos of the product below) distributed and imported by ophthaswissmed philippines inc. ophthaswissmed received a notice of product recall from the oculentis bv, the manufacturer of the above-mentioned medical device product. oculentis received notifications of sporadic late postoperative opacification of lentis iol’s. opacification may compromise the optical transparency of the iol’s in time, potentially leading to a slow reduction in the patient’s visual acuity. studies made by the manufacturer have indicated that opacification could possibly be the result of phosphate remnants from a phosphate-containing cleaning agent used in the production. oculentis assured that all currently produced and all lentis iol’s products on the market with an expiry date of 2020-06 or later are completely unaffected and may be used safely and effectively. all concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested.       attachments: fda advisory no. 2017-288.Pdf.

Device

Lentis Intraocular Lens

Manufacturer

Oculentis BV