BEUDAMED
    FDA Adverse Event Summary report: N

    EC-5000 QUEST

    MDR report key: 5618524 · Received April 28, 2016

    Report

    Report Number
    3002807715-2016-00016
    Date Received
    April 28, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 31, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    UDI-DI
    04987669100028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IN REGARDS TO THE PATIENT INJURY COMPLAINT, NIDEK CLINICAL SPECIALIST AND CUSTOMER SERVICE MANAGER CONTACTED FACILITY ON (B)(4) 2016 TO GATHER ADDITIONAL INFORMATION. A REPRESENTATIVE ((B)(6)) FROM (B)(6) OFFICE CALLED BACK AND INFORMED THAT DOCTOR IS AWARE OF THE ISSUE OCCURRED WITH THIS PATIENT. HE ALSO ASSURED THAT THE PROBLEM IS NOT RELATED TO "NIDEK'S PRODUCT". HOWEVER THE PROBLEM IS RELATED TO THE KERATOME (ZEIMER FEMTO LASER) USED BY SHARPE VISION. AS PER THE INFORMATION FROM NIDEK FIELD SERVICE REPRESENTATIVE, DR (B)(6) USES ZIEMER FEMTO LASER. AFTER THE INVESTIGATION NIDEK WOULD LIKE TO CONFIRM THAT THE PATIENT INJURY OCCURRED IS DUE TO THE KERATOME (ZEIMER FEMTO LASER) AND NOT THE NIDEK INC.'S EC-5000 QUEST. SINCE THE DEVICE IN QUESTION IS NOT MANUFACTURED BY NIDEK INC., ADDITIONAL INFORMATION REGARDING DEVICE EVALUATION IS NOT AVAILABLE. ADDITIONALLY, OTHER INFORMATION RELATED TO THE STATUS OF THE PATIENT INJURY, ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED OR NOT WAS NOT PROVIDED BY THE PATIENT AND/OR THE USER FACILITY AT THE TIME.

    Description of Event or Problem · 1

    NIDEK INC. CUSTOMER SERVICE REPRESENTATIVE (REP.) RECEIVED A CALL ON (B)(4) 2016 FROM GENTLEMEN BY THE NAME OF (B)(6) COMPLAINING THAT HIS GIRLFRIEND RECEIVED LASIK FROM DR (B)(6) ON (B)(6) 2016. PATIENT REPORTED THAT DURING SURGERY, SHE HAD A MAJOR DAMAGE ON ONE EYE. AS PER THE REPORTER, DR (B)(6) INFORMED THAT THE LASER MADE A "J CUT" CAUSING DAMAGE TO THE PATIENT'S EYE (EYE LID). HOWEVER, NIDEK CUSTOMER SERVICE REP. INFORMED (B)(6) THAT NIDEK LASER DOES NOT PERFORM THE CUT AND THAT THERE IS A DIFFERENT PIECE OF EQUIPMENT THAT DOES THAT PORTION. (B)(6) ALSO MENTIONED THAT ON (B)(6) 2016 PATIENT RECEIVED PRK FROM DR (B)(6) ON THE OTHER EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272180 EC-5000 QUEST NIDEK EXCIMER LASER QUEST HQF NIDEK CO., LTD. EC-5000 QUEST 04987669100028

    Patients

    Seq Age Sex Outcome Treatment
    1