Alerta De Seguridad para Complete MoisturePlus contact lens solution

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por AMO.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2007-05-26
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Press release
  • Causa
    Recall of amo contact lens solution consumers of amo complete moistureplus contact lens solution are urged to stop using the product immediately following a voluntary recall of the product by its manufacturer, advanced medical optics (amo). the recall was initiated by amo following reports of acanthamoeba keratitis cases, a rare but serious infection of the cornea, in the united states . "dh is closely monitoring the recall," a spokesman of the department of health (dh) today (may 26) said. information provided by the local importer of the product, amo asia limited, showed that recall action is in progress to take off the product from the shelf at the retailer level and to operate a hotline for enquiries. the spokesman said, "contact lens wearers should discontinue using the product immediately and consult their doctor if they have eye pain, eye redness, blurred vision, sensitivity to light, sensation of something in the eye and excessive tearing or other eye symptoms." he said that dh would liaise with the hospital authority and private eye doctors for more information and to step up surveillance on the associated eye infection. 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 your optometrists/ophthalmologist and follow their instruction 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. close all bottles of contact lens solution 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 lenses 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 or ophthalmologists (eye doctors). seek medical advice from your doctor promptly if symptoms persist despite contact lens is off. ends saturday, may 26, 2007.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    Press release: Recall of AMO Contact Lens Solution
  • Manufacturer
    AMO

Manufacturer

AMO