BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD IOL

    MDR report key: 2589755 · Received May 23, 2012

    Report

    Report Number
    2031924-2012-00042
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    May 1, 2010
    Report Date
    April 23, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN RETURNED TO B+L FOR EVAL TO THE DATE. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT, IMPLANTED WITH THE CRYSTALEN HD500, DEVELOPED ASTIGMATISM DUE TO ONSET OF Z-SYNDROME ONE MONTH POST IMPLANTATION. PRIOR TO LENS EXPLANTATION THE SURGEON PERFORMED A YAG BUT IT WAS UNSUCCESSFUL. THE LENS WAS EXPLANTED AND REPLACED WITH A MONO-FOCAL LENS APPROX 2 YEARS AFTER IMPLANT. THE MOST CURRENT BCDVA WAS REPORTED AS 20/20. PER THE SURGEON THE PT'S PROGNOSIS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD IOL INTRAOCULAR LENS NAA BAUSCH + LOMB HD500 016689

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other