BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3255611 · Received July 26, 2013

    Report

    Report Number
    1119279-2013-00237
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED, THEREFORE IT IS NOT AVAILABLE FOR EVAL. INVESTIGATION OF THIS EVENT 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 PT VISITED THE SURGERY CLINIC COMPLAINING OF DECREASED VISION AND WAS FOUND TO HAVE ENDOPHTHALMITIS THREE DAYS POST IOL IMPLANT. THE PT APPLIED ARTIFICIAL TEARS AND AN ANTI-INFLAMMATORY AGENT AND COMPLETELY RECOVERED BY F/U VISIT ON (B)(6) 2013. ADD'L INFO HAS BEEN REQUESTED. PLEASE REFERENCE MFR# 1119279-2013-00238 FOR THE INSERTER USED DURING IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350670 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI64AOR 4225412

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other EZ-28 DELIVERY SYSTEM