Notificaciones De Seguridad De Campo acerca de Bausch and Lomb ReNu with MoistureLoc Multi-Purpose Solution

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por manufacturer #28616.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
  • Notas adicionales en la data
    3rd Party Publications
  • Causa
    Background information or related documents: the irish medicines board is aware that bausch and lomb have: voluntarily stopping shipment of all renu moisture loc solution manufactured at its facility in greenville, united states advised retailers in the us to remove the renu moisture loc solution from their shelves temporarily recommended that customers in the us switch to another lens care solution this action was taken following multiple reports of fusarium keratitis among contact lens users in singapore, hong kong and the us.  the bausch and lomb investigation into this issue is still ongoing and has not, to date, identified the cause of the problem.  bausch and lomb have informed the imb that no renu moisture loc solution manufactured at the greenville plant is supplied to the european market. bausch and lomb have indicated to the imb that the product supplied to the european market is manufactured at the bausch and lomb facility in italy. to date there have been no confirmed reported incidents of fusarium keratitis related to product manufactured at this european plant. this product is also manufactured in two other plants, in india and china.  bausch & lomb have indicated that no confirmed incidents have been identified relating to renu moisture loc manufactured in these plants either. as such, at this time bausch and lomb do not intend to stop the supply of product in europe. the imb will continue to monitor the issue and will maintain close communication with bausch and lomb and other regulatory agencies. recommendations: the imb recommends that any irish customers who have purchased this product outside the european union or from an internet site should check the product label to determine where it was manufactured. irish customers should discontinue use of any  product manufactured in the us and contact bausch and lomb if they have any concerns. the imb recommends that contact lens users observe good contact lens hygiene practice and follow any recommendations provided by the manufacturer, their optician or other healthcare professional especially in relation to storage, cleaning and insertion of their contact lenses. contact lens users who experience eye symptoms such as pain, redness, excessive tear formation, abnormal sensitivity to light, blurred vision, discharge or swelling remove the contact lenses, discontinue use and consult a doctor. the imb also recommend that healthcare professionals / clinicians with patients presenting with possible eye infections should consider fungal infections as a potential causative organism, investigate accordingly, preserve contact lenses and solutions for analysis, refer the patient if appropriate, and report contact lens related infections to the manufacturer. bausch and lomb have set up a free phone number for irish customers 1800 409077.  further recommendations and further information can be found on the bausch & lomb website www.Bausch.Com and on the website of the food and drug administration www.Fda.Gov/bbs/topics/news/2006/new01354.Html in the united states.