Events

Retiro De Equipo (Recall) de Device Recall Healon EndoCoat Ophthalmic Viscosurgical Device and Healon Duet Dual Pack

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 Abbott Medical Optics Inc (AMO).

¿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
    69704
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0530-2015
  • Fecha de inicio del evento
    2014-11-06
  • Fecha de publicación del evento
    2014-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131399
  • 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
    Aid, surgical, viscoelastic - Product Code LZP
  • Causa
    Amo has received complaints where the finger grip dislodged while depressing the syringe plunger. the finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.
  • Acción
    Abbott Medical Optics issued an Urgent Advisory Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to consult the DFU that is distributed with each device, which contains important warning and precautions for use of the product. Customers were instructed to provide a copy of the Advisory Notice to surgeons and thsoe who need to be aware in their organization. Custommers with questions were instructed to call 877-266-4543. For questions regarding this recall call 714-247-8656.

Device

Device Recall Healon EndoCoat Ophthalmic Viscosurgical Device and Healon Duet Dual Pack
  • Modelo / Serial
    Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012)  Healon EndoCoat Device identification: For Healon EndoCoat, each lot is assigned a unique lot number for traceability. The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned. The numbers 1-6 are sequentially increased representing the manufacturing order number. Example: Lot 024992.   For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha unique batch number. The batch number consists of two alphabetic characters followed by five numeric characters. The first alphabetic character of each batch number designates the manufacturing site. The second alphabetic character of each batch number shall be sequential numbers starting with 30001. Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014).
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.
  • Descripción del producto
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device || 3% sodium hyaluronate || 0.85 mL 30 mg/mL || Sterile A Solution || Sterile EO Packaging and Cannula || Product of USA || Abbott Healon Duet Dual Pack || 0.55 ml OVD || 0.85 ml Healon EndoCoat OVD || Contents: || -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) || -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) || Part Number: || US: VT585U and 57502000 (packaged in Healon Duet 10290080) || OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
  • Manufacturer
    Abbott Medical Optics Inc (AMO)

Manufacturer

Abbott Medical Optics Inc (AMO)
  • Dirección del fabricante
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA