BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 2802360 · Received October 19, 2012

    Report

    Report Number
    1119279-2012-00250
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO BAUSCH + LOMB FOR EVAL. INVESTIGATION OF THIS COMPLAINT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LI61AOR IOL WAS REMOVED INTRAOPERATIVELY DUE TO BENT HAPTIC. AN EZ-28 DELIVERY SYSTEM WAS USED. THE ORIGINAL INCISION WAS ENLARGED, BUT NO SUTURES WERE USED. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY, AND THE PT'S PROGNOSIS WAS DESCRIBED AS EXCELLENT. REFERENCE MDR#: 1119279-2012-00251 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4210312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EZ-28 DELIVERY SYSTEM