BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US IOL

    MDR report key: 540770 · Received January 1, 2004

    Report

    Report Number
    MW1032592
    Event Type
    Malfunction
    Date Received
    January 1, 2004
    Date of Event
    July 1, 2004
    Manufacturer
    US IOL, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTER HAS BEEN SUPPLIED A USIOL MAKE INTRAOCULAR LENS BY THEIR AUTHORIZED REP. THE LENS DIOPTER ON THE PACKAGE, THE LABEL STRIP AND THE LABEL STUCK ON THE STERILE POUCH MENTIONS THE REQUIRED +25.0 BUT THE PRINTED POWER ON THE OUTER AND INNER STERILE POUCH MENTIONS +18.0. ACTUALLY THE OUTER POUCH CONTAINS BOTH THE LABEL MENTIONING THE POWER AS + 25.0 AND THE PRINTED POWER ON THE POUCH ABOVE THE LABEL AS + 18.0.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 04/20/05: AT FACILITY MFR RETRIEVED THE LPD (LEXINGTON PRODUCTION DOCUMENT) AS WELL AS THE VARIOUS LOG BOOKS (LATHING, WAX REMOVAL, TUMBLE POLISHING, DIOPTERING, FINALS, PACKAGING AND SHIPPING). MFR DETERMINED THAT THERE WAS NO ADDITIONAL LENS THAT HAD SOMEHOW GOTTEN INTO THE WRONG BATCH. THE DOCTOR IS NOT WILLING TO RETURN THE LENS FOR FURTHER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US IOL INTRA OCULAR LENS HQL US IOL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *