BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT AO INTRAOCULAR LENS

    MDR report key: 2030708 · Received March 18, 2011

    Report

    Report Number
    1119279-2011-00052
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: THE RETURNED LENS WAS RECEIVED INSIDE THE TIP OF THE DELIVERY DEVICE. VISUAL INSPECTION OF THE LENS FOUND BOTH HAPTICS BENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED DAMAGE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE SILICONE LI61AOR INTRAOCULAR LENS. BASED ON THE INFO RECEIVED, THE CAPSULAR BAG WAS COMPROMISED AND AN ANTERIOR CHAMBER LENS WAS USED INSTEAD. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT AO INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4018904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EZ-28 DELIVERY DEVICE (BAUSCH + LOMB)