BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 3834508 · Received May 2, 2014

    Report

    Report Number
    1119279-2014-00078
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    February 15, 2013
    Report Date
    February 25, 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 IS NOT AVAILABLE TO BE RETURNED TO B+L FOR EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. HYDROVIEW IOL WAS DISCONTINUED AND IS NO LONGER MANUFACTURED BY B+L.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS WAS EXPLANTED DUE TO OPACIFICATION. THIS REPORT REFERS TO THE PATIENT'S LEFT EYE. 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
    264506 HYDROVIEW INTRAOCULAR LENS HQL; INTRAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other