Alerta De Seguridad para Bausch & Lomb intraocular lens HYDROVIEW H60M, manufactured by Bausch & Lomb and distributed between December 1997 and May 2001 with identification number of the lenses started with 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 6E or 6F.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BAUSCH & LOMB.

¿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
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Since 2001, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the manufacturer have continuously monitored associated opacification and explantation reports. To date, a total of 19 centers in the UK have reported cases of opacification to the manufacturer. A total of 88,527 Hydroview lenses have been supplied to the UK in silicone-containing packaging. Of these, 304 (0.3%) were reported to be explanted. A manufacturer-sponsored study suggested that opacification can occur 12 to 25 months after implantation. More recent postmarketing data suggest that typical patients present opacification 12 to 36 months after implantation. In January 2004 the Medicines and Healthcare Products Regulatory Agency - MHRA was informed of the results of a study conducted at a center in the UK. This identified an increase in the rate of explantation of patients who received their lenses between September 2000 and April 2001. This center contacted all patients in this group, inviting them to a consultation to see if they were experiencing such problems. This center reported a revision rate of 4% for lenses implanted between September 2000 and April 2001, although the explanatory rate varied considerably depending on the month of implantation. Other possible influences, besides changes in packaging, from December 1997 and May 2001: the manufacturer confirmed that no change in the industrial parameters was identified that explained the variations in the incidence of opacity. In the light of information, another UK center, in conjunction with the manufacturer, is now conducting a review of all patients who received the Hydroview lenses between September 2000 and April 2001 to identify the extent of the problem. Results of this review are being awaited for the next three months. The Medicines and Healthcare Products Regulatory Agency - MHRA has established direct communication with specialized professionals who agree to the actions listed above as being the most appropriate.
  • Causa
    Bausch & lomb published a letter, addressed to uk health professionals in february 2001, informing its clients of an increased incidence of opacification with hydroview intraocular lenses. while the cause of opacification is multi-factorial, studies by the manufacturer have indicated that surface calcification appears to be linked to the migration of silicone from the packaging onto the surface of the lens. a silicone-containing packaging system was in use from december 1997 until may 2001, when hospital stocks were replaced by lenses in silicone-free packaging. the medicines and healthcare products regulatory agency (mhra) has received no notification of opacification of the hydroview lenses associated with new packaging.
  • Acción
    1) Identify patients implanted with these lenses; 2) Consider contacts with these patients to alert them to a review visit if they are experiencing an opacified vision; 3) Ensure that all patients who have been implanted with affected lenses are aware that they must undergo a review visit if their vision deteriorates in the future; 4) Report all incidents of manufacturer-independent opaque intraocular lens to the Surveillance Unit - UTVIG / GGTPS / ANVISA and its lens manufacturer; 5) Watch out if the UTVIG Technovigilance Unit will publish further information on the Hydroviem IOL opacification incident.


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