BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIOLASE PLUS

    MDR report key: 837614 · Received October 31, 2006

    Report

    Report Number
    2027755-2006-00001
    Event Type
    Other
    Date Received
    October 31, 2006
    Date of Event
    September 19, 2006
    Report Date
    October 18, 2006
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ADMITTED TO MISUSE OF DIODE LASER DURING ITS OPERATION, BY NOT WEARING EYE PROTECTION DURING USE OF THE LASER. THE USE OF EYE PROTECTION IS STATED DURING THE INITIAL TRAINING AND LOCATED WITHIN THE USERS MANUAL. THE PATIENT WAS A DENTAL HYGENIST WITH A Y-SUTURE CATARACT TO BEGIN WITH IN ONE OF HER EYES. THE OPHTHALMOLOGIST DR MENTIONED THESE ARE COMMON AND IS NOT DUE TO THE LASER. WHEN SHE EXAMINED HER PATIENTS EYES, THERE APPEARED TO BE BUBBLES ON BOTH LENSES WHICH INDICATES THE PROCESS OF CATARACTS. THIS AGAIN IS NOT DUE TO THE UNIT MALFUNCTIONG, BUT THE USER NOT FOLLOWING INSTRUCTIONS. THE DIODE ITSELF, EVEN IF REFLECTED OUT OF THE MOUTH, WOULD DISSIPATE EXPONENTIALLY BEFORE REACHING HER EYES, WHICH WOULD BE APPROXIMATELY 18 INCHES IN DISTANCE FROM THE LASER AT THE TIME OF OPERATION. THUS, THE LASER WOULD NOT HAVE THE ABILITY TO PENETRATE AND HARM THE SURFACE. AFTER CONTACTING THE DENTAL OFFICE ON OCTOBER 25, 2006, DR INFORMED US THAT THE LASERSMILE UNIT IS FULLY OPERATIONAL WITH NO ERRORS OR UNUSUAL CONDITIONS, IT HAS BEEN WORKING PERFECTLY ACCORDING TO THE DOCTOR.

    Description of Event or Problem · 1

    OPHTHAMOLOGIST CALLED INQUIRING ABOUT DIODE LASER ISSUES WITH THE EYES BECAUSE HER PATIENT, A DENTAL HYGENIST, USED THE LASERSMILE WITHOUT PROTECTIVE EYEWARE FOR "90 SECONDS" AND NOW CLAIMS THAT HER EYES ARE BOTHERING HER. DOCTOR DOES NOT HAVE PREVIOUS RECORDS ON EYESIGHT; HOWEVER, FROM PATIENT INFORMATION, SHE SUPPOSEDLY HAD A PREVIOUS Y-SUTURE CATARACT ONLY. NOW DR IS NOTICING BUBBLES ON BOTH LENSES WITH MORE PRONOUNCED BUBBLES ON THE RIGHT EYE. LEFT EYE VISION IS 20/20 RIGHT EYE VISION, SUPPOSEDLY EFFECTED, IS 20/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIOLASE PLUS DIODE LASER GEX BIOLASE TECHNOLOGY, INC. 7000694 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other