BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEMINI

    MDR report key: 810399 · Received January 26, 2007

    Report

    Report Number
    2937094-2007-00003
    Event Type
    Other
    Date Received
    January 26, 2007
    Date of Event
    December 28, 2006
    Report Date
    December 28, 2006
    Manufacturer
    LASERSCOPE/AMS
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPORTED TO LASERSCOPE/AMS THAT SHE HAD NOT SEEN A DOCTOR. NO MALFUNCTION OF THE LASER WAS REPORTED. CORRECT EYEWEAR, P/N 0010-0008 WAS SENT TO THE FACILITY. OPTICAL DENSITY FOR THIS EYEWEAR IS SUFFICIENT FOR USE WITH THE GEMINI LASER. OD IS 5 @ 532NM AND 5 @ 1064NM. EYEWEAR WAS SENT BACK TO LASERSCOPE/AMS FOR EVALUATION. PRELIMINARY EVALUATION HAS TAKEN PLACE: THE EYEWEAR DOES NOT EXHIBIT ANY ANOMALIES IN TERMS OF PERFORMANCE AT 532NM AND 1064NM. THEREFORE, INITIAL ASSESSMENT IS THAT THE EYEWEAR IS SAFE FOR USE ON A GEMINI LASER. FURTHER IN-DEPTH ANALYSIS WILL BE PERFORMED AND RESULTS WILL BE PRESENTED A IN FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    PHYSICIAN CONTACTED LASERSCOPE/AMS TO REPORT THAT THERE WAS LIGHT IN HER CENTER VISION DUE TO BAD GLASSES. INFORMATION REPORTED BY THE PHYSICIAN WAS THAT HER RETINA WAS RUINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI LASER GEX LASERSCOPE/AMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other