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.

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.

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.