BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE SQUARE EDGE LENS

    MDR report key: 2181192 · Received July 21, 2011

    Report

    Report Number
    1119279-2011-00133
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION FOUND BOTH HAPTICS BENT NOT MEETING SPECIFICATIONS. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. BASED ON THE CURRENT INFORMATION, WE ARE UNABLE TO DETERMINE ROOT CAUSE OF THE EVENT. INSPECTION AND TEST RECORDS INDICATE THAT THE LOT CONFORMED TO SPECIFICATION AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LI61SE LENS WAS INSERTED INTO THE PATIENT'S RIGHT EYE AND IMMEDIATELY REMOVED AS THE HAPTIC KINKED INTRAOPERATIVELY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. SUTURES WERE NECESSARY TO CLOSE THE WOUND. PLEASE REFERENCE MDR#: 1119279-2011-00134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE SQUARE EDGE LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61SE 4919028

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other EZ-28 DELIVERY DEVICE