BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 2900969 · Received January 3, 2013

    Report

    Report Number
    1119279-2013-00003
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 4, 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 HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS WAS 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. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553 HYDROVIEW INTRAOCULAR LENS HQL / INTRAOCULAR LENS HQL BAUSCH + LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other