BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1915761 · Received December 6, 2010

    Report

    Report Number
    2648035-2010-00236
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P960028/SO11
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) ASSOCIATED WITH THIS REPORT WAS SENT BY THE PHYSICIAN TO AN INDEPENDENT LABORATORY FOR ANALYSIS, RESULTS ARE UNKNOWN AT THIS TIME. IN FOLLOW-UP WITH THE SURGEON, IT WAS LEARNED THE PATIENT HAD A MYOPIC SHIFT OF 2.0 DIOPTERS AND WAS REPORTING GHOSTING OF IMAGES. THE ANTERIOR CHAMBER DEPTH OF THE PATIENT'S EYE WAS REDUCED COMPARED TO THE OTHER IMPLANTED EYE. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT. IOL NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RECEIVED BY THE MANUFACTURER FOR ANALYSIS. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THE TEST RESULTS FROM THE SURGEON WITHOUT SUCCESS. THE MANUFACTURING DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A REVIEW OF THE POST MARKET SURVEILLANCE DATABASE SHOWS NO OTHER REPORTS RECEIVED FOR LENSES MANUFACTURED IN THIS LOT. A ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. ALL INFORMATION AVAILABLE IS CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED FROM THE SURGEON ON (B)(6) 2010 WAS AN INQUIRY ASKING IF AN INTRAOCULAR LENS(IOL) WAS IMPLANTED ANTERIOR SIDE TO THE POSTERIOR COULD IT CAUSE A MYOPIC SHIFT OF -2.0 DIOPTERS. IT WAS LATER LEARNED THAT THE IOL WAS EXPLANTED BY THE SURGEON ON (B)(6) 2010 WITHOUT COMPLICATION AND SENT TO AN INDEPENDENT LABORATORY FOR ANALYSIS. PATIENT'S VISUAL ACUITY AT THE TIME OF EXPLANT WAS 6/9 WITH MINIMAL GHOSTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REZOOM MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS NXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention