BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1983875 · Received February 4, 2011

    Report

    Report Number
    1119279-2011-00030
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED LENS REVEALED THAT ONE HAPTIC AND A PIECE OF THE OPTIC WERE TORN OFF. ALSO, IT WAS NOTED THAT THE OTHER HAPTIC WAS BENT AND THE OPTIC WAS TORN IN TWO PLACES. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED DAMAGED CONDITION OF THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF AN LI61AOR INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. INTRAOPERATIVELY, THE SURGEON NOTED THAT A HAPTIC WAS PROTRUDING, AND SUBSEQUENTLY REMOVED THE IOL AND IMPLANTED ANOTHER INTRAOCULAR LENS. THE INCISION WOUND WAS SUTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR # 1119279-2011-00031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4026725

    Patients

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