BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 3010471 · Received March 14, 2013

    Report

    Report Number
    1119279-2013-00071
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 13, 2013
    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 INFO, 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 SCHEDULED TO BE EXPLANTED DUE TO OPACIFICATION. THE LOT AND SERIAL NUMBER WERE NOT PROVIDED, THEREFORE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE LENS MODEL IS HYDROVIEW 1.0. ADD'L INFO WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108395 HYDROVIEW INTRAOCULAR LENS HQL / INTAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other