BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 1871818 · Received October 16, 2010

    Report

    Report Number
    2648035-2010-00191
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P8040/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. CAUSE OF THIS EVENT IS UNDETERMINABLE AT THIS TIME. PRIOR TO RELEASE, THE LENS MET ALL MANUFACTURING SPECIFICATIONS. WILL CONTINUE TO MONITOR AND TREND ALL REPORTS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. THE LENS OPTIC WAS CUT IN HALF WITH ONE DISTORTED HAPTIC NOTED. PRIOR TO RELEASE THE IOL MET ALL MANUFACTURING SPECIFICATIONS. THE RESULTS OF OUR INSPECTION SUGGEST THIS EVENT IS USER RELATED AND NOT MANUFACTURING RELATED. WE WILL CONTINUE TO MONITOR AND TREND ALL REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT DURING ROUTINE CATARACT SURGERY AND DURING IMPLANT OF THE INTRAOCULAR LENS (IOL), THE LENS OPTIC CRACKED. THE LENS WAS CUT IN HALF AND REMOVED THROUGH AN ENLARGED INCISION. THERE WERE NO FURTHER COMPLICATIONS AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A CHECK SUPPLY LINE ALARM ON THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) HAD DISCONNECTED THE SOLUTION BAG AND CONNECTED IT TO THE HEATER LINE. THE HP THEN ENDED THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention