BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD IOL

    MDR report key: 2792298 · Received October 12, 2012

    Report

    Report Number
    2031924-2012-00080
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    February 7, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED IN THE PT'S EYE AND WILL THEREFORE NOT BE RETURNED TO BAUSCH + LOMB FOR EVAL. 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 THE PT PRESENTED WITH GLARE, "BUTTERFLY FLICKERING" AND BRIGHTNESS OF LIGHT POST CRYSTALENS IMPLANTATION IN THE LEFT EYE. THE PT WAS REFERRED TO A RETINA SPECIALIST. THE RETINA SPECIALIST PERFORMED OPTICAL COHERENCE TOMOGRAPHY (OCT) AND FOUND DISTINCT CYSTOID MACULAR EDEMA (CME). THE PT WAS PRESCRIBED PRED FORTE AND DICLOFENAC FOR TREATMENT. THE SURGEON AND RETINAL SPECIALIST CONCLUDED THAT THE LENS WAS WELL POSITIONED AND SHOWED NO DEFECTS. THE PHYSICIANS BELIEVED A LENS EXPLANT WAS NOT RECOMMENDED AS IT WOULD NOT ALLEVIATE THE PT'S SYMPTOMS. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD IOL NAA/INTRAOCULAR LENS NAA BAUSCH + LOMB HD500 017531

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other