Alerte De Sécurité sur ReNu contact lens solutions

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
    2006-03-04
  • Pays de l'événement
  • Source de l'événement
    DH
  • 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 traced and recorded 23 cases of fungal corneal infection (keratitis) among local contact lens users following reports of this kind were found in singapore and hong kong recently. a chp spokesman said these cases comprised six males and 17 females aged between 16 and 51. twenty of them sought medical consultations from public hospitals and three others received medical treatments in private hospitals between may 2005 and february this year. "dh has contacted 22 of these patients. twenty-one claimed that they were users of b&l renu multipurpose contact lens solution," the spokesman said. the spokesman said preliminary results of sterility tests on 20 samples of b&l renu contact lens solutions by dh are negative. "we are maintaining close communication with other agencies for further findings and developments," he said. meanwhile, dh!|s hotline has so far received more than 2 000 enquiries from members of the public. 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; 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 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; 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 eye doctors if symptoms of keratitis developed such as eye pain, redness etc.

Device

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

Manufacturer

B&L