BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 2010509 · Received March 1, 2011

    Report

    Report Number
    1119279-2011-00050
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND BOTH HAPTICS BENT, WITH ONE HAPTIC SLIGHTLY TWISTED. 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 FINDING THAT RELATE TO THE REPORTED ISSUE. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING A CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE L161SE INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING IMPLANTATION THE SURGEON NOTICED AN UNSPECIFIED DEFECT ON THE LENS. ADDITIONAL INTERVENTION WAS PERFORMED BY ENLARGING THE INCISION TO REMOVE AND REPLACE THE IOL INTRAOPERATIVELY. THE PHYSICIAN IMPLANTED ANOTHER L161SE INTRAOCULAR LENS SUCCESSFULLY WITH NO COMPLICATIONS. REFERENCE MDR #1119279-2011-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH + LOMB L161SE 4013226

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention EZ-28 DELIVERY DEVICE (B+L)