Device Recall SoftPerm (synergicon A) contact lenses

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including PR; and countries including: Australia, Austria, Argentina, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Dubai (United Arab Emirates), Finland, France, Great Britain, Greece, Hungary, Iceland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Netherlands, Oman, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and Venezuela.
  • Descripción del producto
    SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA || SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    CIBA Vision Puerto Rico, Inc., El Jibaro Industrial Park Lots 1 & 2, Route 173 Km 1.1, Cidra PR 00739
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA