BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT INTRAOCULAR LENS

    MDR report key: 3890658 · Received May 30, 2014

    Report

    Report Number
    1119279-2014-00117
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND BOTH HAPTICS AND SMALL PIECES OF THE OPTIC TORN OFF. ONE HAPTIC WITH A SMALL PIECE OF THE OPTIC IS LYING LOOSE IN THE CARRIER. THE HAPTIC IS ALSO BENT. THE OTHER HAPTIC WAS NOT RETURNED. THE OPTIC IS TORN NEARLY TO THE CTR OF THE OPTIC. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DAMAGE. THE LOT HISTORY RECORD WAS REVIEWED FOR THE LENS AND THERE WERE NO NON-CONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. THE PRODUCT WAS DEEMED ACCEPTABLE FOR RELEASE. BASED ON THE CURRENT INFO A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IT IS TO BE NOTED THAT THE INSERTER USED IN THIS EVENT WAS NOT A VALIDATED B+L INSERTER FOR THIS LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LENS INSERTION THE CAPSULAR BAG WAS DAMAGED. THE LENS WAS REMOVED AND A VITRECTOMY WAS PERFORMED. A DIFFERENT MODEL LENS WAS IMPLANTED. THE DOCTOR BELIEVES THE PT WILL ULTIMATELY DO WELL. THE INSERTER USED IN THIS EVENT WAS NOT A B+L INSERTER. THE VISCOELASTIC THAT WAS USED DURING THIS EVENT IS REPORTED UNDER 1119279-2014-00118.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319729 SOFPORT INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH + LOMB LI61SE 4355640

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other AMVISC VISCOELASTIC