BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1760351 · Received July 18, 2010

    Report

    Report Number
    2648035-2010-00136
    Event Type
    Injury
    Date Received
    July 18, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL WAS NOT RECEIVED FOR ANALYSIS. THE CAUSE OF THIS EVENT REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED BUT INSTEAD USER RELATED. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. AN UPDATE TO THIS REPORT WILL BE SUBMITTED IF LENS IS RECEIVED FOR ANALYSIS. DEVICE NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND MEASURED CORRECT FOR DIOPTER AS LABELED, 12.0 D. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED 18 DAYS AFTER THE INITIAL IMPLANT WITHOUT COMPLICATION. REASON STATED WAS THAT THE PATIENT'S VISION WAS NOT GOOD, AND THE IOL WAS CHANGED TO A HIGHER POWER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE INFUSION DEVICE DELIVERED 20 UNITS OF INSULIN INSTEAD OF THE INTENDED 2 UNITS OF INSULIN. THE PATIENT BECAME UNCONSCIOUS. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE INCIDENT FOR OTHER REASONS, AND HE RECEIVED IMMEDIATE ASSISTANCE (TYPE OF TREATMENT NOT PROVIDED). HIS BLOOD GLUCOSE MEASURED 1.6 MMOL/L (29 MG/DL). HE STATED, HE IS UNSURE IF HE INCORRECTLY PROGRAMMED THE INSULIN AMOUNT OR IF THE INFUSION DEVICE DELIVERED THE AMOUNT INCORRECTLY. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention