BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-PIECE PMMA LENS

    MDR report key: 2223897 · Received August 18, 2011

    Report

    Report Number
    1119279-2011-00151
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P840039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTS THAT THE LENS WAS REMOVED BECAUSE THE PT'S ZONULES WERE NOT STRONG ENOUGH TO SUPPORT THE LENS. THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION FOUND BOTH HAPTICS BENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. INSPECTION AND TEST RECORDS INDICATE THAT THIS LOT CONFORMED TO SPECIFICATION AT THE TIME OF RELEASE. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER, IN THE SURGEON'S OPINION THE EVENT IS DUE TO THE PT'S ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE EZE-60 LENS WAS INSERTED INTO THE POSTERIOR CHAMBER OF THE PT'S LEFT EYE THE DOCTOR DECIDED TO REMOVE THE LENS AND IMPLANT AN ANTERIOR CHAMBER LENS. THE DOCTOR REPORTED THAT THE PT'S ZONULES WERE NOT STRONG ENOUGH TO HOLD THE EZE-60 LENS. THE ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. THE ORIGINAL INCISION WAS ENLARGED AND SUTURES WERE REQUIRED TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE-PIECE PMMA LENS INTRAOCULAR LENS HQL BAUSCH + LOMB EZE-60 2026404

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention