BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 4886356 · Received July 1, 2015

    Report

    Report Number
    3005087645-2015-00005
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 30, 2015
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K083921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO DEVICE WAS RETURNED, SYNERGEYES CONDUCTED A PROCESS REVIEW AND NO CORRELATION WAS FOUND BETWEEN THE DEVICE HISTORY RECORD AND THE ALLEGED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE ECP INDICATED THAT A SUPERFICIAL DEFECT IN THE SUPERIOR CORNEA HAD OCCURRED, THE DEFECT WAS ALSO INDICATED AS AN ULCER. THE ECP INDICATED THAT THE EVENT WAS NOT SIGHT THREATENING, HOWEVER VIGAMOX WAS "THERAPEUTICALLY" APPLIED FOUR TIMES DAILY FOR 10 DAYS WHILE THE PATIENT WAS INSTRUCTED TO DISCONTINUE LENS WEAR. THE EVENT HAD RESOLVED ON (B)(6) 2015. AT TIME OF CONTACT WITH THE ECP, THE PATIENT HAD RETURNED TO USING AN OLDER LENS WITH SOME LENS AWARENESS, WHILE THE REPLACEMENT LENS HAD NOT BEEN DISPENSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429193 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES SM73F-0625+STDSM 064496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention