BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT INTRAOCULAR LENS

    MDR report key: 2230561 · Received August 12, 2011

    Report

    Report Number
    1119279-2011-00148
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED FROM THE SURGEON INDICATES THAT THE PT IS NOW BLIND. ACCORDING TO THE SURGEON, THE BLINDNESS IS NOT DUE TO THE IOL, BUT RATHER DUE TO OTHER EXTENUATING ISSUES WITH THE PT. DESPITE ATTEMPTS TO OBTAIN FURTHER INFO REGARDING THE EXTENUATING ISSUES, NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE CUSTOMER. THE LENS WAS RETURNED TO B&L. VISUAL INSPECTION FOUND ONE HAPTIC SLIGHTLY BENT. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE CONDITION OF THE LENS. THE CAUSE OF THE OBSERVED DAMAGE CANNOT BE DETERMINED. 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 THE RELEASED LENSES FROM THIS LOT CONFORMED TO SPECIFICATION AT THE TIME OF RELEASE. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S CAPSULE BROKE WHILE THE SURGEON ATTEMPTED THE IMPLANTATION OF THE LI61AOR LENS INTO THE PT'S LEFT EYE. A VITRECTOMY WAS PERFORMED AND NO INTRAOCULAR LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4021509

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention