BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 3961685 · Received June 16, 2014

    Report

    Report Number
    3005087645-2014-00017
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K083921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE FOLLOWING INFORMATION WAS OBTAINED: BASE CURVE WAS MEASURED BY RADIUS SCOPE AND POWER WAS MEASURED BY LENSOMETER. BOTH BC AND POWER WERE FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. NO DEFECTS WERE NOTED ON SURFACE AND NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE DEVICE HISTORY REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE PATIENT (PT) SUSTAINED REDNESS AND IRRITATION IN LEFT EYE (OS). REPORT STATE: "THERE IS SOMETHING ON THE LENS IRRITATING PT'S EYE. ON (B)(6) 2014 SYNERGEYES CONTACTED DR (B)(6) AND IT IS WAS ASSERTED THAT THE REDNESS IN THE EYE OF THE PT WAS AN INJURY DUE TO THE FACT THAT A MEDICATION WAS REQUIRED TO RESOLVE THE SYMPTOM; HOWEVER, THE ALLEGED INJURY RESOLVED IN A "COUPLE OF DAYS". THE PT HAD RECEIVED THE REPLACEMENT LENSES AND WAS TRYING THEM OUT. ON (B)(6) 2014 SYNERGEYES SPOKE WITH (B)(6), AN OFFICE ATTENDANT FOR DR (B)(6) AND THE FOLLOWING INFORMATION WAS OBTAINED: (B)(6) 2014 WAS THE DATE OF THE EVENT. REDNESS OCCURED IN THE OS. VIGAMOX WAS THE PRESCRIBED MEDICATION THAT RESOLVED THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353258 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES SP79S-0375+025030 058220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention