BEUDAMED
    FDA Adverse Event Other Summary report: N

    YAG LASER

    MDR report key: 436905 · Received January 6, 2003

    Report

    Report Number
    MW1027193
    Event Type
    Other
    Date Received
    January 6, 2003
    Date of Event
    April 16, 2002
    Report Date
    January 6, 2003
    Manufacturer
    *
    Product Code
    LOI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2001, PT HAD SUCCESSFUL ELECTIVE SURGERY TO REPLACE THE LENS IN EACH EYE TO CORRECT SEVERE FARSIGHTEDNESS AND ASTIGMATISM. A YEAR LATER A CLOUDINESS DEVELOPED IN LEFT EYE, WHICH DR DESCRIBED AS A SECONDARY MEMBRANE AND SAID IT WAS VERY COMMON. A PROCEDURE USING THE YAG LASER WAS PERFORMED AND PT HAD A FOLLOW-UP VISIT ON 5/17/2002. WHILE ON VACATION IN LATE 7/2002, PT NOTICED A DISCOLORATION ON THE OUTER RIM OF LEFT EYE. DR DIAGNOSED THIS AS PTERYGIUM. WHEN PT ASKED IF THIS WAS CAUSED BY THE YAG LASER, HE ASSURED PT THAT IT WAS DUE TO SUN EXPOSURE. PT DOESN'T PLAY GOLF OR TENNIS, AND DOESN'T SUN BATHE OR WORK OUTDOORS, SO PT'S NOT EXPOSED TO THE SUN ENOUGH TO CAUSE THIS KIND OF DAMAGE. PT ALSO WEARS SUNGLASSES WHEN THEY ARE IN THE SUN. PT WOULD LIKE TO KNOW IF THERE ARE REPORTS OR RESEARCH ABOUT THE YAG LASER CAUSING A PTERYGIUM-LIKE GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YAG LASER LASER FOR TREATMENT OF SECONDARY MEMBRANE FOLLOWING CATARACT LOI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other