Alerte De Sécurité sur ReNu multipurpose 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 Bausch & Lomb (Hong Kong) Ltd.

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
    Dh keeps close watch on fungal corneal infections in singapore the department of health (dh) supports the decision of bausch & lomb (hong kong) ltd (b&l) to voluntarily suspend sales of its renu multipurpose solution in hong kong. a dh spokesman today (february 22) said the arrangement is a prudent and precautionary measure in view of the detection of cases of fungal corneal infections (keratitis) involving users of the solution in singapore and hong kong. dh expressed concern over the development in the country and held a teleconference with singapore ministry of health yesterday (february 21) to exchange information on fungal infections of the two places. the department also met with representatives of b&l, microbiological experts, ophthalmologist, optometrists and consumer council on the same day to discuss the situation in hong kong. the department advised b&l to look into the problem and take necessary measures to protect local consumer. updated information from singapore showed that there have been 39 cases since 2005 with a spike of cases in january 2006. thirty-four of these 39 cases said that they had used a renu multipurpose solution by b&l. in hong kong, the average number of fungal keratitis cases between june 2005 and january this year based on the hospital authority's in-patient discharge records was two to three per month. "of the 16 cases interviewed by dh during this period, 12 reported having used the product on repeated interviews. dh is conducting sterility tests on the product, and preliminary results are expected later this week." "dh and its singapore counterparts are jointly investigating the cause for this phenomenon," the spokesman said. dh also approached international authorities to inquire if cases of fungal keratitis involving contact lens users were also reported in other countries, he added. "we will continue to maintain close liaison with b&l to monitor the development and will provide updated information to the public," the spokesman said. he pointed out that a letter to doctor has been issued earlier alerting them to fungal keratitis and asking them to refer such cases to ophthalmologists. "dh has solicited support from optometrists and ophthalmologists to enhance public education on the proper use of contact lens and contact lens solutions," the spokesman said. contact lens users are advised to consult optometrists/ophthalmologists for professional advice, and to observe the following measures: always wash hands properly with soap and water and dry them before handling contact lens, contact lens solutions or related accessories; do not wet your lens with saliva, bottled water or tap water; follow wearing hours and replacement schedule recommended by your optometrists/ophthalmologists; storage case should be cleaned, rinsed and dried after every use to avoid micro-organism 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; follow the instruction of cleaning and disinfection procedures by your optometrists/ophthalmologists; discard contact lens disinfections after one month of opening; do not wear lenses for duration longer than recommended and replace them as recommended by your optometrists/ophthalmologists; regular check up by your optometrists/ophthalmologists; remove the contact lens whenever you feel discomfort or redness and seek medical advice promptly if symptoms persist despite contact lens is off; and consult ophthalmologists if symptoms of keratitis developed such as eye pain, redness etc. dh has set up a hotline (2125 2727) to answer public enquiries. it will be operated up to 9 pm today and during office hours from tomorrow onwards.


  • Modèle / numéro de série
  • Description du dispositif
    Press release: DH keeps close watch on fungal corneal infections in Singapore
  • Manufacturer