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
    Public reminded to clean contact lens properly the centre for health protection (chp) of the department of health today (february 18) called on members of the public to properly clean and disinfect contact lens to prevent keratitis – inflammation of the cornea of the eye. the appeal was made following seven cases of fungal corneal infections were reported in singapore earlier this year. all of them are users of contact lens. information obtained from the singapore ministry of health indicated that of the 19 affected persons identified since may 2005, 18 used bausch and lomb's (b&l) renu multipurpose contact lens solution, a chp spokesman said. as for hong kong, the spokesman said the number of fungal kertitis cases admitted to public hospitals has remained stable in the past six months, recording a monthly average of two to three cases. "chp investigations last year revealed that some local fungal keratitis patients had also recalled using the b&l contact lens solution. "chp has earlier requested b&l manufacturer to examine its product and the company determined that the incident was not attributable to the product. sterility tests performed by the chp for samples of the products bought from local market were also negative for fungal infections," the spokesman said. in response to the recent increase in the number of cases in singapore, the chp has contacted the b&l manufacturer to obtain more update information and investigate further about possible relationship between their product and fungal keratitis cases. the chp will send letters to doctors alerting them about the situation and to be on the lookout for fungal keratitis infections. more b&l contact lens solutions will be tested for fungus and other microbes. the spokesman reminded users of soft contact lens to observe the following in the prevention of 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.


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