Alerte De Sécurité sur ReNu multipurpose contact lens solution

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par B&L.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Update on cases of fungal corneal infections the centre for health protection (chp) of the department of health (dh) has received four more reports of fungal corneal infection (keratitis) since early march, bringing the total number of contact lens users affected to 27 since the infection was firstly reported in may 2005. a chp spokesman said the four recent cases comprised three males and one female aged between 17 and 43. "of the 27 patients, 26 were interviewed and 25 of them claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the manufacturer has voluntarily suspended sales of the contact lens solution in question from the local market since february this year as a prudent measure to protect consumers. "we are also maintaining close communication with the health authorities of singapore and the united states where cases of this kind were also reported in order to obtain the latest information and findings from them," he said. in the united states, 109 cases with suspected fungal keratitis were under investigation. of the 30 patients for whom complete data were available, 28 were soft contact lens users. twenty-six of them reported using b&l contact lens solution. in singapore, out of the 75 affected persons, 59 were sure of the contact lens solution used. of these, 56 said they had used b&l renu multipurpose contact lens solution. the spokesman reminded contact lens users to observe the following measures to prevent contact lens associated infection: always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories; attend regular check up by optometrists/ophthalmologist and follow their instructions of cleaning and disinfection procedures for contact lenses and the accessories; follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists. do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists; practise proper contact lens cleaning and care regimes. both sides of the lenses must be rubbed with the fingers for 20 seconds and rinsed thoroughly before soaking overnight in multi-purpose solution. rinse the lenses with saline before wearing the contact lenses next time; the multi-purpose solution in the lens storage case must be changed everyday even if the lenses are not used daily; all contact lens solution should be capped properly after use; discard contact lens solutions after one month of opening; storage case should be cleaned, rinsed and dried after every use to avoid micro-organism growth contamination; all contact lenses, solutions and accessories should be stored in a cool and dry place; disinfect the case weekly by soaking in just-boiled water for 10 minutes; replace case every three months; disposable contact lens must not be used beyond their recommended disposal period; do not wet your lens with saliva, bottled water or tap water; remove the contact lens whenever you feel discomfort or redness and seek advice from your optometrists/ophthalmologists. seek medical advice promptly if symptoms persist despite contact lens is off.


  • Modèle / numéro de série
  • Description du dispositif
    Press release: Update on cases of fungal corneal infections
  • Manufacturer