Events

Retiro De Equipo (Recall) de Device Recall BIOM 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 Insight Instruments, 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
    56246
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2221-2010
  • Fecha de inicio del evento
    2010-05-12
  • Fecha de publicación del evento
    2010-08-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93054
  • 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
    Ocular Surgery Irrigation Device - Product Code KYG
  • Causa
    Insight instruments, inc., stuart, fl is recalling cornea coat 2.5% hydroxypropylmethylcellulose solution in 1.5 ml syringe due to a potential weakness of the peel pouch seals. products affected are item numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of biom pack.
  • Acción
    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

Device

Device Recall BIOM PACK
  • Modelo / Serial
    Cornea Coat Lot Codes:  M408080708,  M409570708,  M414420808,  M415940808,  M415950808,  M416620908,  M419300908,  M421610908,  M421680908,  M422951008,  M427661108,  M430041108,  M435381208,  M442120109,  M44499,  M44744,  M44897.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.
  • Descripción del producto
    BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411). || Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. || Item # 40201: || Item Lot # Cornea Coat Lot # Expiration Date || M423801008 M419300908 2010-07 || M427731108 M419300908 2010-07 || M428631008 M419300908 2010-07 || M434211208 M422951008 2010-08 || M439670109 M422951008 2010-08 || M443700109 M435381208 2010-09 || M44887 M442120109 2010-10 || Item # 40202: || Item Lot # Cornea Coat Lot # Expiration Date || M427641008 M419300908 2010-07 || M45414 M435381208 2010-09 || Item # 40203: || M416600908 M415950808 2010-06 || M422941008 M416620908 2010-07 || M427651108 M422951008 2010-08 || M442710109 M435381208 2010-09 || M44870 M442120109 2010-10 || Item # 40204: || Item Lot # Cornea Coat Lot # Expiration Date || M421580908 M416620908 2010-07 || M435201208 M422951008 2010-08 || M45645 M435381208 2010-09 || Item # 40205: || Item Lot # Cornea Coat Lot # Expiration Date || M410510708 M409570708 2010-05 || M412790708 M409570708 2010-05 || M419280908 M415950808 2010-06 || M420850908 M415950808 2010-06 || M421100908 M416620908 2010-07 || M421120908 M416620908 2010-07 || M424361008 M419300908 2010-07 || M425821008 M421680908 2010-07 || M426731008 M421680908 2010-07 || M428601008 M419300908 2010-07 || M429531108 M421680908 2010-07 || M430851108 M421680908 2010-07 || M431051108 M422951008 2010-08 || M433111108 M422951008 2010-08 || M435531208 M430041108 2010-09 || M440700109 M430041108 2010-09 || M441790109 M435381208 2010-09 || M442560109 M430041108 2010-09 || M443450109 M422951008 2010-08 || M443930109 M442120109 2010-10 || M44605 M442120109 2010-10 || M44896 M44499 2010-11 || M45099 M44499 2010-11 || M45243 M435381208 2010-09 || M45248 M44897 2010-12 || M45866 M44897 2010-12 || M45870 M435381208 2010-09 || Item # 10206: || Item Lot # Cornea Coat Lot # Expiration Date || M418460908 M416620908 2010-07 || M434741208 M422951008 2010-08 || M45646 M435381208 2010-09
  • Manufacturer
    Insight Instruments, Inc.

Manufacturer

Insight Instruments, Inc.
  • Dirección del fabricante
    Insight Instruments, Inc., 2580 Se Willoughby Blvd, Stuart FL 34994-4701
  • Empresa matriz del fabricante (2017)
    Insight Instruments, Inc.
  • Source
    USFDA