BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100 REFRACTOR

    MDR report key: 4001942 · Received June 10, 2014

    Report

    Report Number
    3002807715-2014-00003
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    2936921-4/17/2014-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2014 THROUGH US DISTRIBUTOR (B)(4). RT-5100 NEAR POINT ROD FELL DOWN AND HIT OPTOMETRIST IN HER EYE AREA ON (B)(6) 2014. THE OPTOMETRIST VISITED EMERGENCY ROOM FOR MEDICAL EVALUATION AND TREATMENT TO HER EYE AND WAS EVALUATED BY HER PHYSICIAN. THE REQUIRED MEDICAL TREATMENT IS UNKNOWN. OPTOMETRIST WAS ABLE TO RETURN TO WORK THAT SAME DAY. SHE REQUIRED NO FURTHER TREATMENT. SPECIFIC INFORMATION REGARDING THE INDIVIDUAL THAT WAS INJURED IS NOT BEING DISCLOSED TO (B)(4). SINCE THE INFORMATION RECEIVED INDICATES A POTENTIAL RISK OF SERIOUS INJURY, NIDEK INC. AND NIDEK CO., LTD. (B)(4) DETERMINED TO SUBMIT EACH MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337141 RT-5100 REFRACTOR NONE HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention