BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415450 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00006
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    January 1, 2000
    Report Date
    October 10, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INVESTIGATION BY NIDEK INC. CONCLUDES THAT "WE PROVIDE NECESSARY INFO AND TRAINING TO SURGICAL DOCTORS TO PREVENT ADVERSE EVENTS." "BASED ON THE INFO PRESENTED, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INJURY," AND "IF FURTHER INFO IS REC'D, WE WILL SUBMIT A F/U." NIDEK CO., LTD. ASKED NIDEK INC. FOR ADD'L INVESTIGATION. SINCE NIDEK CO., LTD ALSO COULD NOT HAVE FURTHER INFO TO PERFORM ADD'L INVESTIGATION AS A MFR, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY. IF FURTHER INFO IS REC'D, WE WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    NIDEK WAS NOT FORMALLY NOTIFIED BY THE FDA WITH A LETTER BASED ON MAUDE EVENT REPORT, THE REPORT (B)(4) STATED A PT HAD LASIK PROCEDURE WITH EC-5000 EXCIMER. LASER IN 2000. PER THE MAUDE EVENT REPORT, LASIK PROCEDURE PERFORMED IN 2000. IN 2006, EYES WENT "BAD" DUE TO THIN CORNEAS. LOSS OF CORRECTED SIGHT. DIAGNOSED WITH POST-LASIK KERATOCONUS OR AS THE PT STATED "LASIK INDUCED THINNING OF CORNEAS KERATOCONUS." PRESCRIBED GAS PERMEABLE CONTACT LENSES THAT ARE VERY UNCOMFORTABLE TO WEAR DUE TO SURGERY. PT SOUGHT OUT MEDICAL INTERVENTION. MEDICAL INTERVENTION IS CURRENTLY REQUIRED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522624 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention