BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-5000

    MDR report key: 5325770 · Received December 23, 2015

    Report

    Report Number
    3002807715-2015-00053
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Date of Event
    December 14, 2014
    Report Date
    December 6, 2015
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/6/2015 NIDEK CLINICAL SPECIALIST RECEIVED AN EMAIL FROM (B)(4) MDR TEAM REGARDING THE MAUDE REPORT AT THE FDA SITE. THE REPORT WAS SUBMITTED BY THE PATIENT TO FDA. AS PER THE REPORT PATIENT HAD SURGERY WITH NIDEK EC-5000 ON (B)(6) 2014. AFTER ONE YEAR PATIENT DEVELOPED SIDE EFFECTS INCLUDING DOUBLE VISION AND TRIPLE VISON. PATIENT ALSO COMPLAINED ABOUT HALOS AND STARBURSTS AROUND LIGHTS IN LOW LIGHT CONDITIONS, LOSS OF CONTRAST SENSITIVITY AND DRY EYES. AS THE PATIENT STARTED TREATMENT FOR THE DRY EYES, THE QUALITY OF THE VISION GOT DETERIORATED. THE BIGGEST CONCERN OF THE PATIENT IS THAT THE SIDE EFFECTS OF THE SURGERY WERE NOT EXPLAINED PROPERLY BEFORE THE SURGERY. AT THIS TIME NIDEK INC. DOES NOT HAVE ANY ADDITIONAL DETAILS OF THE PATIENT STATUS. THE DEVICE HAS NOT BEEN EVALUATED SINCE THE DETAILS REGARDING THE SERIAL NUMBER OR THE NAME OF THE USER FACILITY USING THE DEVICE ARE NOT AVAILABLE. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS A DUE DILIGENCE NIDEK INC. WOULD LIKE TO SUBMIT THE MEDWATCH FORM FOR THIS ISSUE.

    Description of Event or Problem · 1

    NIDEK (B)(4) HAS IDENTIFIED A MAUDE REPORT ON THE FDA SITE. NIDEK (B)(4) MDR TEAM SENT AN EMAIL NOTIFICATION TO NIDEK INC. CLINICAL SPECIALIST ON 12/6/2015. AS PER THE REPORT PATIENT SUBMITTED A VOLUNTARY REPORT TO THE FDA. PATIENT HAD LASER SURGERY IN 2014 WITH NIDEK EC-5000. ONE YEAR AFTER PATIENT DEVELOPED MANY SIDE EFFECTS INCLUDING DOUBLE AND TRIPLE VISION, HALOS AND STARBURSTS, DRY EYES AND DETERIORATION OF THE QUALITY OF VISION. (B)(4). REPORT NUMBER: MW5058135 AS PER THE REPORT, PATIENT REPORTED AS "I GOT A LASER (ALL LASER): FEMTOSECOND) SURGERY IN (B)(6) 2014 FOR A +3. 5D HYPEROPIA ON BOTH EYES, WITH A "STANDARD" LASER (NIDEK EC 5000) WITH NO PERSONAL TREATMENT AND NO EYE-TRACKER ENABLED. ONE YEAR LATER, I HAVE A RESIDUAL +1. 25D ON THE RIGHT EYE AND +1. 5D ON THE LEFT EYE BECAUSE OF THE INSUFFICIENT PROGRAM OF ABLATION (BETTER THAN GETTING A MYOPIA THOUGH) AND MY TREATMENT IS NOT WELL CENTERED AROUND MY PUPIL. THIS LEADS TO A MODERATE DOUBLE VISION ON THE RIGHT EYE, AND A MODERATE TRIPLE VISION ON THE RIGHT EYE. THOSE SYMPTOMS ARE VISIBLE IN ALL CONDITIONS OF LIGHT. I HAVE HALOS AND STARBURSTS AROUND LIGHTS IN LOW LIGHT CONDITIONS, LOCALIZED ON THE BOTTOM OF THE LIGHTS BECAUSE OF THE TREATMENT WHICH WAS RECEIVED TOO LOW. IT BECAME WAY MORE DIFFICULT TO DRIVE MY NIGHT BUT STILL POSSIBLE, LUCKY ME WHEN I READ OTHER TESTIMONIES. I ALSO HAVE LOST A LOT OF CONTRAST ESPECIALLY IN LOW LIGHT CONDITION. I ALSO GOT DRY EYES, WHICH IS IMPROVED WITH DROPS, BUT DETERIORATE THE QUALITY OF MY VISION. I HAVE TO CHOOSE BETWEEN SEEING A LITTLE BIT BETTER BUT FEELING BEARABLE PAIN IN THE EYES AND TAKE THE RISK TO DAMAGE MY CORNEA, OR LOSING 2 LINES OF BSCVA AND UCVA BY USING DROPS. THIS SURGERY WAS SO FAR THE WORST THING I HAVE EVER DONE FOR ME IN MY LIFE. I COULD HAVE KEPT MY LENSES AND GLASSES AND A GOOD CORRECTED VISION. THIS WAS AN UNNECESSARY SURGERY. SADLY, I GOT TRAPPED BY THE SATISFACTION RATE (AROUND 97% THEY SAY) AND THE SAFENESS THAT ALL SURGEONS AND CLINICS SHOW FOR THIS UNNECESSARY SURGERY. THE PROBLEM IS THAT ALL THOSE SIDE EFFECTS ARE NOT TAKEN INTO CONSIDERATION. MY SURGERY IS CONSIDERED A SUCCESS FOR EXAMPLE. THE BIGGEST PROBLEM IS THAT THE IMPORTANCE OF SIDE EFFECTS ARE NOT WELL EXPLAINED AND THE SURGEONS ALWAYS SAY THAT THEY ARE TEMPORARY TO MAKE YOU FEEL SAFER, EXCEPT THEY OFTEN DON'T: 50% OF PEOPLE GET AT LEAST ONE OF THOSE (PROFANITY) SIDE EFFECTS TEMPORARILY, AND MORE THAN 20% AFTER SIX MONTHS OR FOR EVER. THIS DOES NOT INCLUDE DRY EYE. THE AMOUNT OF MONEY AT STAKES MAKES A LOT OF SURGEONS GREEDY AND PRACTICE WITHOUT ANY HONESTY REGARDING THE SIDE EFFECTS THAT CAN EASILY BE DEVASTATING FOR PEOPLE'S LIVES, EVEN WITH A 20/70 VISION SEEING DOUBLE MAKES YOU THINK OF YOUR MISTAKE DOING THIS SURGERY EVERY SINGLE MINUTE OF YOUR UPCOMING LIFE. RIGHT NOW I HAVE ALMOST NO PERSPECTIVE OF IMPROVING MY VISION, A RETREATMENT ONE YEAR AFTER THE FIRST SURGERY IS NOT WORTH THE RISK: POSSIBLE EPITHELIAL GROWTH AND MORE SEVERE DRY EYE CONDITION, NOT VERY GOOD RESULT WITH RETREATMENT, THAT CAN EVEN WORSEN THE VISION AGAIN ETC. I PROBABLY LOST FOREVER THE POSSIBILITY TO SEE WELL LIKE BEFORE. I TRY TO THINK MYSELF HAPPY TO STILL BEING ABLE TO DO MOST OF THE THINGS IN MY LIFE THAT I WAS DOING BEFORE THIS SURGERY, BUT I AM AFRAID OF WHAT CAN COME NEXT. SOME PEOPLE EXPERIENCE NEW ISSUES YEARS AFTER THEIR SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850359 EC-5000 EXCIMER LASER SYSTEM HQF NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1