BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    MDR report key: 1013789 · Received March 14, 2008

    Report

    Report Number
    1920664-2008-00362
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    p910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, THE PT SUFFERED A CORNEAL BURN DURING THE PHACOEMULSIFICATION PORTION OF THE PROCEDURE. STITCHES WERE USED TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC-VIOLET SHIELD INTRAOCULAR LENS HQC BAUSCH & LOMB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention