Events

Retiro De Equipo (Recall) de Device Recall SoftPerm (synergicon A) contact lenses

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por CIBA Vision Puerto Rico, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57714
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1976-2011
  • Fecha de inicio del evento
    2011-02-01
  • Fecha de publicación del evento
    2011-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97072
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lenses, soft contact, daily wear - Product Code LPL
  • Causa
    Out of specification values were obtained for sterility testing. the ph of the saline solution may be higher than the spec (up to ph 8.6 compared to a spec limit of ph 7.8). the osmolarity of the saline solution may be lower than specification (263 mosm/kg compared to a spec limit of 270).
  • Acción
    The firm, CIBA Vision, sent two letters of notification to its customers. First letter "IMPORTANT PRODUCT INFORMATION" dated June 2010 and the second "URGENT: Voluntary Product Recall" dated February 1, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1) complete the requested information on the attached SoftPerm (synergicon A) Lenses Reply Form and drop the form in the mail within 10 business days and 2) If they have any of the recalled SoftPerm (synergicon A) lenses (shipped to you after March 1, 2009) still in their possession, return as follows: Package the product and affix the prepaid UPS return label and ship within 10 business days or mail to CIBA VISION Corporation, c/o Stericycle Pharmaceutical Services, 2670 Executive Drive, Ste. A, Indianapolis, IN 46241, Atth: SoftPerm Recall. CIBA ask customers to please not include other products, lots, kits, packs, or competitor's products with their shipment. In addition, CIBA will issue a credit to the customers account upon receipt of the returned product. Please feel free to contact Stericycle at 877-542-5928 or CIBA VISION Technical Consultation Department at 1-800-241-7468 should you have any questions or concerns.

Device

Device Recall SoftPerm (synergicon A) contact lenses
  • Modelo / Serial
  • Clasificación del producto
    Ophthalmic Devices
  • 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
    CIBA Vision Puerto Rico, Inc.

Manufacturer

CIBA Vision Puerto Rico, Inc.
  • 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)
    Novartis Ag
  • Source
    USFDA