BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 2801011 · Received October 18, 2012

    Report

    Report Number
    1119279-2012-00248
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    June 28, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS REQUESTED BUT NOT RETURNED TO BAUSCH & LOMB. DESPITE ATTEMPTS TO OBTAIN THE LENS LOT NUMBER, IT WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE CURRENT INFORMATION, THE EXACT ROOT CAUSE OF THE IOL OPACIFICATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS WAS EXPLANTED DUE TO OPACIFICATION OF THE LENS. THE LOT AND SERIAL NUMBER WERE NOT PROVIDED, THEREFORE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE LENS MODEL IS HYDROVIEW 1.0. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROVIEW INTRAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other