Retiro De Equipo (Recall) de AERO IOL Injection System, Z28 Cartridges

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 Aaren Scientific 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Folders and injectors, intraocular lens (iol) - Product Code MSS
  • Causa
    The recommended storage temperature on the label is incorrect.
  • Acción
    Aaren Scientific sent an Urgent Medical Device Recall letter dated August 31, 2017. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1.Compare your inventory against the above list. 2. STOP using and REMOVE from your inventory all affected Z28 listed above. 3. Complete and return the attached Customer Reply Form EVEN IF YOU HAVE NO INVENTORY affected by this recall, to Aaren Scientific, Inc. Quality Management at (909) 937-1033 or email to within 3 business days of receipt of this letter. Upon notification, Aaren Scientific, Inc. will supply you with a Return Good Authorization Number to replace all remaining customer inventory of the affected product immediately. Aaren Scientific, Inc. requires this information for reconciliation purposes with regulatory agencies. No other Aaren Scientific, Inc. Z28 Cartridges are affected by this action. This notice should be shared with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have inventory of any of the Z28 Cartridges with the batch numbers listed, please contact Customer Support at (909) 937-1033 to arrange pick up of lenses to be returned. Page 2 of 4 If you have product complaints or adverse events to report regarding the use of the Z28 cartridge, please inform Aaren Scientific, Inc. by calling. When reporting a complaint, please provide the Z28 cartridge batch number and, if a patient was involved, the date of surgery, a description of the event and patient outcome. For questions regarding this recall call 909-906-5119.


  • Modelo / Serial
    Lot numbers and expiration dates: 160204, 1/31/2018; 160505, 4/30/2018; 161006, 9/30/2018; 161018, 9/30/2018; 161028, 9/30/2018; 161219, 11/30/2018; and 170120, 12/31/2018.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide distribution including Puerto Rico.
  • Descripción del producto
    AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA. || Used to fold and insert the firm's IOL's.
  • Manufacturer


  • Dirección del fabricante
    Aaren Scientific Inc., 1040 S Vintage Ave Ste A, Ontario CA 91761-3631
  • Empresa matriz del fabricante (2017)
  • Source