BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGELLAN MAPPER

    MDR report key: 465613 · Received June 6, 2003

    Report

    Report Number
    1041845-2003-00001
    Event Type
    Other
    Date Received
    June 6, 2003
    Date of Event
    May 27, 2003
    Report Date
    June 5, 2003
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Product Code
    HJB
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/27/03: IN RESPONSE TO FILING OF THE OSHA DOCUMENTS WHICH ASSERT THAT RADIATION FROM THE MAGELLAN MAPPER CORNEAL TOPOGRAPHER MAY HAVE CAUSED A KERATITIS WITH SECONDARY IRITIS IN REPORTER'S EMPLOYEE, CO IS OFFERING THE FOLLOWING AS INCONTROVERTIBLE EVIDENCE THAT NOT ONLY IS THERE NO SCIENTIFIC OR CLINICAL BASIS FOR THIS CLAIM, BUT THAT IT IS IN FACE IMPOSSIBLE. TO THAT END IF IT IS POSSIBLE TO FILE AN AMENDED REPORT IT WOULD BE GREATLY APPRECIATED. CO WILL FIRST ADDRESS THE ISSUE OF THE FDA CLASS OF THE PRODUCT VERSUS THE CLASS OF THE RED LASER THAT IS USED TO ALIGN THE INSTRUMENT IN Z. THE INSTRUMENT IS CLASS 1 AND REQUIRES NO 510K. THE LASER, EMITTING RED LIGHT AT 635-670 NM, IS A CLASS 2 DEVICE, BUT IS ELECTRONICALLY CONTROLLED WITH DOUBLE FEEDBACK LOOPS THAT LIMIT ITS OUTPUT TO THAT OF A CLASS 1 DEVICE. FAILURE OF THESE LOOPS WILL RESULT IN THE LASER NOT OPERATING. IN ADDITION FDA PROTOCOLS FOR CLASS 1 DEVICES REQUIRE THAT THERE BE NO OPTICAL COMPONENTS THAT COULD FAIL THAT WOULD ALLOW GREATER RADIATION TO FALL UPON EYE. THERE ARE NO SUCH COMPONENTS IN THE MAGELLAN MAPPER. SECONDLY, WHAT WOULD HAPPEN IF THE IMPOSSIBLE OCCURRED AND THE LASER SOMEHOW WAS POWERED UP TO CLASS 2 RADIATION? THE FACT IS THAT THE RETINA, NOT THE CORNEA WOULD BE AFFECTED. THERE IS NO POSSIBILITY THAT A DIFFUSE KERATITIS WOULD BE THE RESULT OF SUCH AN INCIDENT AS THE CORNEA IS FOR PRACTICAL PURPOSES TRANSPARENT TO RED LIGHT AT THE WAVELENGTH AND MAXIMUM POWER EMITTED BY THE LASER. THE EFFECT OF RED LIGHT IS QUASI THERMAL IN NATURE. SINCE RED LIGHT IS NOT ABSORBED IN THE CORNEA, IT HAS NO THERMAL EFFECT THERE. IN ADDITION, THE LASER USED IN THE INSTRUMENT IS A SMALLSPOT ON THE CORNEA. SO IF ANY EFFECT OCCURRED IT WOULD NOT BE DIFFUSED THROUGHOUT THE CORNEA. NOTE THAT THE CORNEA IS A GOOD ABSORBER OF UV LIGHT, SO ONE MIGHT QUESTION THE DIODES THAT ARE USED FOR ILLUMINATING THE CONE. THESE DIODES HAVE A VERY SMALL RANGE OF WAVELENGTHS IN THEIR EMISSIONS THAT ARE NO WHERE NEAR THE UV SPECTRUM. SO THE ONLY UV LIGHT PRESENT WOULD BE AMBIENT IN NATURE. THE MOST PROBABLE REASON FOR THE PT'S KERATITIS WAS DRYNESS SECONDARY TO THE 80 EXAMINATIONS THAT WERE PERFORMED IN A 2 HOUR PERIOD, WHICH WAS NECESSITATED DUE TO PROBLEMS ENCOUNTERED IN IMAGE ACQUISTION BECAUSE THE MAGELLAN SOFTWARE WAS BEING RUN ON WINDOWS XP AND NOT WINDOWS 2000 AS SPECIFIED IN EARLIER MEETINGS AND IN E-MAILS IN MARCH AND APRIL. THERE IS ALSO THE POSSIBILITY OF AN UNDERLYING CONDITION THAT WAS EXASPERATED BY THE DRYNESS. THESE ARE FAR MORE PROBABLE SCENARIOS THAN ANY CAUSE ATTRIBUTED TO THE MAGELLAN.

    Description of Event or Problem · 1

    PERFORMING REPENTIBILITY & REPRODUCTIBILITY TESTING ON MAGELLAN CORNEAL TOPOGRAPHER. AFTER 10 MINUTES EYES BECAME IRRITATED & DRY. CORNEA OF EYE WAS RED, IRRITATED AND PAINFUL IN BRIGHT LIGHT. PRODUCT IS PROTOTYPE AND USED A CLASS II LASER TARGET.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 6/27/03: IN RESPONSE TO FILING OF THE OSHA DOCUMENTS WHICH ASSERT THAT RADIATION FROM THE MAGELLAN MAPPER CORNEAL TOPOGRAPHER MAY HAVE CAUSED A KERATITIS WITH SECONDARY IRITIS IN REPORTER'S EMPLOYEE, CO IS OFFERING THE FOLLOWING AS INCONTROVERTIBLE EVIDENCE THAT NOT ONLY IS THERE NO SCIENTIFIC OR CLINICAL BASIS FOR THIS CLAIM, BUT THAT IT IS IN FACT IMPOSSIBLE. TO THAT END IF IT IS POSSIBLE TO FILE AN AMENDED REPORT IT WOULD BE GREATLY APPRECIATED. CO WILL FIRST ADDRESS THE ISSUE OF THE FDA CLASS OF THE PRODUCT VERSUS THE CLASS OF THE RED LASER THAT IS USED TO ALIGN THE INSTRUMENT IN Z. THE INSTRUMENT IS CLASS 1 AND REQUIRS NO 510K. THE LASER, EMITTING RED LIGHT AT 635-670 MM, IS A CLASS 2 DEVICE, BUT IS ELECTRONICALLY CONTROLLED WITH DOUBLE FEEDBACK LOUPES THAT LIMIT ITS OUTPUT TO THAT OF A CLASS 1 DEVICE. FAILURE OF THESE LOOPS WILL RESULT IN THE LASER NOT OPERATING. IN ADDITION FDA PROTOCOLS FOR CLASS 1 DEVICES REQUIRE THAT THERE BE NO OPTICAL COMPONENTS THAT COULD FAIL THAT WOULD ALLOW GREATER RADIATION TO FALL UPON THE EYE. THERE ARE NO SUCH COMPONENTS IN THE MAGELLAN MAPPER. SECONDLY, WHAT WOULD HAPPEN IF THE IMPOSSIBLE OCCURRED AND THE LASER SOMEHOW WAS POWERED UP TO CLASS 2 RADIATION? THE FACT IS THAT THE RETINA, NOT THE CORNEA WOULD BE EFFECTED. THERE IS NO POSSIBILITY THAT A DIFFUSE KERATITIS WOULD BE THE RESULT OF SUCH AN INCIDENT AS THE CORNEA IS FOR PRACTICAL PURPOSES TRANSPARENT TO RED LIGHT AT THE WAVELENGTH AND MAXIMUM POWER EMITTED BY THE LASER. THE EFFECT OF RED LIGHT IS QUASI THERMAL IN NATURE. SINCE RED LIGHT IS NOT ABSORBED IN THE CORNEA, IT HAS NO THERMAL EFFECT THERE. IN ADDITION, THE LASER USED IN THE INSTRUMENT IS A SMALL SPOT ON THE CORNEA. SO IF ANY EFFECT OCCURRED IT WOULD NOT BE DIFFUSED THROUGHOUT THE CORNEA. NOTE THAT THE CORNEA IS A GOOD ABSORBER OF UV LIGHT, SO ONE MIGHT QUESTION THE DIODES THAT ARE USED FOR ILLUMINATING THE CONE. THESE DIODES HAVE A VERY SMALL RANGE OF WAVELENGTHS IN THEIR EMISSIONS THAT ARE NO WHERE NEAR THE UV SPECTRUM. SO THE ONLY UV LIGHT PRESENT WOULD BE AMBIENT IN NATURE. THE MOST PROBABLE REASON FOR THE EMPLOYEE'S KERATITIS WAS DRYNESS SECONDARY TO THE 80 EXAMINATIONS THAT WERE PERFORMED IN A 2 HOUR PERIOD, WHICH WAS NECESSITATED DUE TO PROBLEMS ENCOUNTERED IN IMAGE ACQUISITION BECAUSE THE MAGELLAN SOFTWARE WAS BEING RUN ON WINDOWS XP AND NOT WINDOWS 2000 AS SPECIFIED IN EARLIER MEETINGS AND IN EMAILS IN MARCH AND APRIL. THERE IS ALSO THE POSSIBILITY OF AN UNDERLYING CONDITION THAT WAS EXASPERATED BY THE DRYNESS. THESE ARE FAR MORE PROBABLE SCENARIOS THAN ANY CAUSE ATTRIBUTED TO THE MAGELLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN MAPPER CORNEAL TOPOGRAPHER HJB NIDEK TECHNOLOGIES SRL MAGELLAN MAPPER *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other