Alerte De Sécurité sur Product Trade Name: ReNu with Moisture LOC - Multiation Solution. N. Anvisa Reg.: 80136060092

Safety alert

822

2006-04-10

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The us food and drug administration (fda) and the us centers for disease control and prevention (cdc) have published on the fda website at http://www.Fda.Gov/bbs/topics/news/2006/ new01354.Html, an alert to healthcare professionals and contact lens wearers about the growing number of eye infections caused by the fusarium fungus in the united states. although not so frequent in that country, this type of infection is serious, since it can cause permanent blindness. according to the article, some patients reported loss of vision, requiring corneal transplantation. the fda and the cdc are investigating 109 cases of suspected fusarium contamination in 17 us states. the cause has not yet been detected. of the 30 cases investigated, 28 were users of contact lenses and 2 were non-users. of the 28 users, 26 reported using the product contact lens solution brand renu moisture loc, manufactured by the american company bausch & lomb, or a generic company of the same company, within a month before presenting the infection. five other users reported having used other solutions concurrently, and nine patients reported sleeping with their lenses. the alert highlights cases of corneal infection with fusarium fungus in asia in contact lens wearers in november 2005. in february 2006, bausch & lomb voluntarily suspended the sale of renu multipurpose solutions in singapore and hong kong, after the various notifications of infection among contact lens wearers. in brazil the product renu is imported and distributed by the company bl indústria ótica ltda - baush & lomb.

- In the United States, the CDC is working on investigations with the company Bausch & Lomb to identify other possible causes, in order to act in the prevention and control of this type of infection. - The American Bausch & Lomb Company informed the FDA that it voluntarily halted the marketing of the product ReNu Moisture Loc during the investigation process and requested that all users of contact lenses that make use of the product in question be careful and report to their respective ophthalmologists any signs or symptoms of eye infection. - In Brazil, BL Indústria Ótica Ltda informed Anvisa that it will take the following preventive / corrective actions in relation to the investigation process, which is in progress: 1) Adoption of control measures in the Brazilian territory, implying the suspension of the commercialization of the product in Brazil until the conclusion of the investigations; 2) Send samples of lots that are in the company's stock, for analysis in an external laboratory; 2) Availability, until Monday, April 17, of information on the company's website including a release with the main information. This release is being passed on to all the commercial area of ​​the company BL Indústria Ótica Ltda., For visits to the main clients, aiming to clarify doubts; 3) Definition, until April 17, 2006, of new strategies of action, for the products that are in the stock of the company; 4) Preparation of a document explaining the situation and training of all its SAC team, in order to support the questions and doubts coming from consumers. The company informs that all the contacts are being registered by the SAC and that to the moment no complaint is related to the appearance of fungi. 5) Communication to Anvisa of new facts that affect the current strategy for the treatment of this situation.