BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1912680 · Received December 2, 2010

    Report

    Report Number
    9614546-2010-00066
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. WHILE WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT OUR INVESTIGATION REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. LENS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    IN FOLLOW-UP WITH THE ACCOUNT IT WAS LEARNED THE EXPLANTED INTRAOCULAR LENS WAS DISCARDED AT THE SURGERY CENTER. OUR INVESTIGATION WAS LIMITED TO A REVIEW OF THE BATCH RECORDS AND POST MARKET SURVEILLANCE DATABASE. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO ADDITIONAL COMPLAINTS FROM THIS ORDER NUMBER WERE RECEIVED. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL BUT INSTEAD THE PATIENT'S INABILITY TO ADJUST TO THE MULTIFOCALITY OF THE LENS. ALL AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE INTRAOCULAR LENS WAS EXPLANTED WITHOUT COMPLICATION 4 MONTHS AFTER IMPLANT DUE TO THE PATIENT'S UNWANTED HALOS AND GLARE. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER ASSEMBLY ISN'T MOVING UP OR DOWN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZM900

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention