BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 524296 · Received May 7, 2004

    Report

    Report Number
    1644019-2004-00015
    Event Type
    Injury
    Date Received
    May 7, 2004
    Date of Event
    June 3, 2003
    Manufacturer
    ALCON-HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ORIGINAL SURGERY AND SECOND SURGERY TOOK PLACE WITHIN ONE TO TWO WEEKS OF EACH OTHER; HOSPITAL NOT NOTIFIED OF FOREIGN BODY UNTIL PAYMENT DISPUTE MARCH 2004. PIECE OF METAL FOUND ON IRIS ONE DAY POST-OP. ORIGIN: UNKNOWN, POSSIBLY FROM PHACO. TIP HAD BEEN DISCARDED AT TIME OF SURGERY; UNABLE TO EXAMINE. SECOND SURGERY WAS OUTPATIENT IN 06/2003; HOME SAME DAY. OUTCOME REPORTED AS EXCELLENT. NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON-HOUSTON STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *