BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 2030035 · Received March 25, 2011

    Report

    Report Number
    9614546-2011-00016
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MULTIFOCAL INTRAOCULAR LENS WAS RECEIVED CUT IN HALF ACROSS THE OPTIC. VISUAL INSPECTION OF THE OPTIC PARTS TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS NOT RECEIVED FOR ANALYSIS. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO OTHER COMPLAINTS FROM THIS ORDER NUMBER WERE RECEIVED. BASED UPON THE ABOVE AND THE FACT THAT NO LENS WAS AVAILABLE, NO FURTHER INVESTIGATION COULD BE PERFORMED. THIS SPECIFIC COMPLAINT ANALYSIS IS INCONCLUSIVE. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT. DEVICE NOT RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS NOT RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE INITIAL MULTIFOCAL IMPLANT WAS EXCHANGED FOR A MONOFOCAL LENS SUGGESTING THE PATIENT WAS NOT ABLE TO ADAPT TO THE MULTIFOCALITY OF THE LENS. ALL INFORMATION AVAILABLE IS CONTAINED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED 5 MONTHS AFTER INITIAL IMPLANT. REASON STATED WAS THE PATIENT'S COMPLAINT OF BLURRED VISION. THE MULTIFOCAL LENS WAS EXCHANGED FOR A MONOFOCAL WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention