BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK EC-5000 EXCIMER LASER SYSTEM

    MDR report key: 3415447 · Received October 11, 2013

    Report

    Report Number
    3002807715-2013-00003
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    May 20, 2002
    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

    NIDEK INC. CONCLUDES THAT "INVESTIGATION WAS PERFORMED AFTER A LETTER FROM FDA HAD BEEN REC'D," "EVEN THOUGH MAUDE DESCRIBES THAT THE INJURY OCCURRED IN 2002, WE HAVE NO REPORTED DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE REPORTED ADVERSE EVENT FROM 05/03/2010 UNTIL WE RECEIVE NOTIFICATION FROM FDA." "WE PROVIDED NECESSARY INFO AND TRAINING TO SURGICAL DOCTORS WHO USE THE EC-5000 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

    ON (B)(6) 2010, NIDEK INC. REC'D A LETTER STARTING MAUDE EVENT REPORT RELATED TO THE EC-5000 EXCIMER LASER SYSTEM. THIS LETTER STATED AN UNK PT HAD BILATERAL HYPEROPIC LASIK ON (B)(6) 2002 BY THE NIDEK EXCIMER LASER BEFORE IT WAS FDA APPROVED FOR HYPEROPIC TREATMENTS. THE PT NOW SUFFERS FROM IRREGULAR ASTIGMATISM AND BLURRY VISION. THIS MAUDE REPORT WAS CREATED BY A PHYSICIAN THAT HAS SEEN THE UNK PT. ACCORDING TO THIS INFO, THE PT SOUGHT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522617 NIDEK EC-5000 EXCIMER LASER SYSTEM NONE LZS NIDEK CO., LTD. EC-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention