BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT SQUARE EDGE LENS

    MDR report key: 3133393 · Received May 24, 2013

    Report

    Report Number
    1119279-2013-00168
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY BAUSCH + LOMB TO DATE. 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 AN INTRAOCULAR LENS WAS EXPLANTED/EXCHANGED FOR ANTERIOR CHAMBER LENS INTRAOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231609 SOFPORT SQUARE EDGE LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB LI61SE 4212105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other