BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EC-5000

    MDR report key: 10124516 · Received June 5, 2020

    Report

    Report Number
    0002936921-2020-00001
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    October 23, 2019
    Report Date
    June 22, 2020
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    LZS
    PMA / PMN Number
    P970053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NIDEK INC. SERVICE MANAGER COMMUNICATED WITH THE USER FACILITY ON (B)(6) 2020 TO OBTAIN FURTHER INFORMATION. NIDEK INC. COULD NOT SCHEDULE SERVICE BECAUSE THE FACILITY USES THIRD PARTY TO PERFORM SERVICES. THE FACILITY RESPONDED THAT THEIR EC-5000 EXIMER LASER HAS BEEN WORKING PROPERLY. ADDITIONALLY, THE FACILITY HAS NOT SEEN THE PATIENT SINCE THE LAST PATIENT VISIT ON (B)(6) 2020. THE DOCTOR DID NOT FIND ANY ISSUE WITH THE PATIENT AND THE PATIENT HAD 20/20 VISION ACCORDING TO THE DOCTOR AT THE LAST VISIT ON (B)(6) 2020. SINCE NIDEK INC. IS UNABLE TO PERFORM DEVICE ANALYSIS FOR THE REPORTED DEVICE, FURTHER INVESTIGATION WILL NOT PROCEED.

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR SUBMISSION ON 5-JUNE-2020.

    Additional Manufacturer Narrative · 1

    NIDEK INC. SERVICE MANAGER WAS ABLE TO VERIFY THE FACILITY WHERE THE PATIENT RECEIVED TREATMENT. DR. (B)(6) HAS MET WITH THE PATIENT ON (B)(6) 2020 AND VERIFIED THE PATIENT'S VISION WAS 20/20. AT THIS TIME, EVALUATION ON THE EC-5000 HAS NOT BEGUN, A SUPPLEMENTAL FOLLOW-UP WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT VOLUNTARILY SUBMITTED REPORT MW5094387 THROUGH THE MEDWATCH PROGRAM TO THE FDA ON MAY 1, 2020. FDA FORWARDED THE INFORMATION TO NIDEK INC ON MAY 7, 2020 THROUGH MAIL. NIDEK INC BECAME AWARE OF THIS EVENT ON JUNE 1, 2020. NIDEK INC EMPLOYEES HAVE RETURNED TO THE OFFICE ON JUNE 1, 2020 FROM THE MANDATORY SHUTDOWN DUE TO COVID-19. THE PATIENT REPORTED FOLLOWING TO FDA: VISION PROBLEMS; MAIN PROBLEM: BRIGHT COLORED OBJECTS/TEXT ON DARK BACKGROUNDS NOW GLOW IN ANYTHING LESS THAN BRIGHT SETTINGS. THE DARKER IT IS AND THE FARTHER AWAY THE SUBJECT THE WORST IT GETS. THE WORST CASE I FREQUENTLY DEAL WITH IS PLAYING A VIDEO GAME OR WATCHING A MOVIE IN THE DARK AND SEEING STUFF LIKE WHITE SUBTITLE TEXT GLOWING, USER INTERFACE ELEMENTS GLOWING, ACTORS GLOWING, REALLY ANYTHING LIGHT AGAINST A DARK BACKGROUND. THIS IS NOT LIMITED TO SCREENS HOWEVER; EVEN LOOKING ACROSS A ROOM AT SOMEONE WITH A WHITE SHIRT OR FAIR SKIN STANDING AGAINST A DARK WALL. THEIR OUTLINE WILL GLOW. ON A PURE BLACK OLED SCREEN (BLACK PIXELS EMIT NO LIGHT) WITH PURE WHITE TEXT IF I LOOK CAREFULLY THERE'S A FUZZINESS ALMOST A STARBURST LIKE EFFECT TO THE GLOW AND IT'S FAIRLY UNIFORM AROUND THE ENTIRE OUTLINE. ALPHAGAN/BRIMONIDINE TARTRATE DROPS TO SHRINK MY PUPILS MOSTLY FIXES THIS PROBLEM (LIKE 80% PROBABLY) WHEN USED UNTIL THEY WEAR OFF. WITH MY JOB AS A VIDEO GAME DEVELOPER THIS IS EXTREMELY FRUSTRATING FOR ME BECAUSE THESE SORT OF BRIGHT OBJECT/TEXT/UI ELEMENTS ON DARK BACKGROUNDS. SCENARIOS ARE COMMON. EVEN HAVING WINDOWS OPEN BUT NOT IN DIRECT SUNLIGHT IS STILL NOT BRIGHT ENOUGH TO COMPLETELY FIX THIS AT A DISTANCE OF JUST COMPUTER MONITOR ON MY DESK. SECOND PROBLEM: AFTER LASIK THERE IS A SUBTLE BACKGROUND "LIGHT POLLUTION" I NOTICE MOST EASILY OVER DARK OBJECTS. ITS APPEARANCE IS LIKE A VERY PAINT VERSION OF WHAT HAPPENS WHEN YOU STARE AT A LIGHT BULB FOR A MOMENT AND THEN LOOK AWAY, STILL SEEING THAT RESIDUAL GLOW. I NOTICE IT MORE IN DIMMER ENVIRONMENTS. THIRD PROBLEM: I CAN'T SEE CLEARLY AT VERY CLOSE DISTANCES TO MY FACE LIKE I COULD BEFORE, THIS PART OF MY VISION IS NOW BLURRY. I HAVE TO MOVE AN OBJECT AT LEAST 18CM AWAY FROM MY EYES BEFORE IT BECOMES CLEAR. BEFORE SURGERY I COULD HOLD AN OBJECT A GOOD BIT CLOSER AND STILL FOCUS CLEARLY ON IT. I THINK THIS MIGHT ALSO BE A SPHERICAL ABERRATION SIDE EFFECT SO SAME CAUSE AS THE MAIN ISSUE ABOVE. THERE ARE OTHER ISSUES I NOTICE THAT I THINK ARE RELATED TO THE ONES ABOVE. IN DIMLY-LIT SETTINGS SUCH AS A PARTY INDOORS I FIND IT HARDER TO FOCUS ON PEOPLE AT A MEDIUM DISTANCE AWAY FROM ME; MY DEPTH PERCEPTION FEELS OFF AND THEIR OUTLINE SEEMS TO BLEND INTO THE BACKGROUND MORE. INDOORS WHEN SOMEONE WALKS IN FRONT OF A BRIGHT WINDOW OR MONITOR THE LIGHT COMING FROM BEHIND THEM "WRAPS" AROUND THEIR OUTLINE NOW, OBSCURING THEM A BIT AT LEAST AROUND THE EDGES. CAR HEADLIGHTS/STREET LAMPS/ETC., AT NIGHT HAVE THE COMMONLY REPORTED STARBURSTING/HALOING EFFECTS TO A DISTRACTING/ANNOYING EXTENT BUT NOT SO BAD THAT I CAN'T SAFELY DRIVE AT NIGHT. PUPIL SIZE MEASURED AT 7MM IN LOW LIGHT. SURGERY OPTICAL ZONE WAS ONLY 6MM, DEVICE NOT CAPABLE OF A LARGE ENOUGH OPTICAL ZONE TO AVOID COMPLICATIONS. FDA SAFETY REPORT ID#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589590 EC-5000 EXCIMER LASER LZS NIDEK CO. LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other