BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 2003556 · Received February 22, 2011

    Report

    Report Number
    1119279-2011-00045
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P840039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF RETURNED LENS FOUND BOTH HAPTICS BENT NOT MEETING CURRENT STANDARDS. THE DELIVERY DEVICE WAS NOT RETURNED. 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 FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS ATTEMPTING TO IMPLANT THE LI61AO LENS BUT THE HAPTICS COULD NOT BE POSITIONED PROPERLY. THE SURGEON ENLARGED THE INCISION, REMOVED THE LENS, AND IMPLANTED AN ANTERIOR CHAMBER LENS. IN ADDITION, A VITRECTOMY WAS PERFORMED. REFERENCE MDR #1119279-2011-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT ADVANCED OPTICS ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB LL61AOR 4028106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EZ-28 DELIVERY DEVICE (B&L)