BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 14372 · Received June 28, 1994

    Report

    Report Number
    MW1002623
    Event Type
    Malfunction
    Date Received
    June 28, 1994
    Date of Event
    June 9, 1994
    Report Date
    June 16, 1994
    Manufacturer
    DGR, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAPTIC WAS OBSERVED AS BROKEN ON THE FIELD. LENS WAS REMOVED FROM FIELD WITH NO PT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS INTRAOCULAR LENS HQL DGR, INC. SP386BN+20

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR