Alerta De Seguridad para AMO contact lens solutions

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

¿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
  • País del evento
  • Fuente del evento
  • 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
    Dh monitoring recall of four amo contact lens solution the department of health is monitoring the voluntary recall of specific lots of four types of contact lens solutions by its manufacturer from the local market due to a concern about their sterility. the concerned contact lens solutions, manufactured by advanced medical optics, inc. are: lens plus ocupure saline 360 ml (lot no.: zb02767, zb03156, zb03174, zb03191) complete protec formula multi-purpose solution 350ml (lot no.: zb03266) complete moistureplus multi-purpose solution 60ml sample pack (lot no. zb03194) complete moistureplus multi-purpose solution 60ml sample pack (lot no. zb03194) a dh spokesman said that the company has notified the department that these lots are being recalled because of production-line problems at its manufacturing plant in mainland, which could affect the sterility of the product. the spokesman said, "so far, dh has not received any report of related injury." he said, "users should stop using the affected lots and should consult their doctors in case of discomfort or infection. they may call the company’s hotlines at 2401 5811/2 in case of queries." 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/wednesday, november 22, 2006 nnnn.


  • Modelo / Serial
  • Descripción del producto
    Press release: DH Monitoring Recall of Four AMO Contact Lens Solutions
  • Manufacturer