BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL 1 PIECE

    MDR report key: 2210987 · Received August 12, 2011

    Report

    Report Number
    9614546-2011-00065
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED CUT IN 2 PIECES. BATCH RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A VISUAL INSPECTION OF THE PRESENT OPTIC PARTS TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. OUR INVESTIGATION REVEALED NO PRODUCT DEFICIENCIES SUGGESTING THIS EVENT WAS NOT CAUSED BY THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LENS WAS EXPLANTED 7 WEEKS AFTER IMPLANT AND NOT 3 WEEKS AS INITIALLY REPORTED.

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN RECEIVED FOR ANALYSIS. PRIOR TO RELEASE TO THE MARKET IT MET ALL MANUFACTURING SPECIFICATIONS. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LENS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS 3 WEEKS AFTER IMPLANT. THE REASON STATED WAS THE PATIENT'S INTOLERANCE OF HALOS AND GLARE. NO INJURY TO THE PATIENT DURING THE SECONDARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL 1 PIECE MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention