BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES, INC. DIAGNOSTIC A LENS SET

    MDR report key: 865910 · Received June 8, 2007

    Report

    Report Number
    3005087645-2007-00008
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 8, 2007
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLICATION RARE BUT NOT UNKNOWN, NO EVIDENCE OF MALFUNCTION OF THE DEVICE BUT RATHER AN INHERENT RISK OF CONTACT LENS WEAR.

    Description of Event or Problem · 1

    DR OF OPTOMETRIC CLINIC STATED THAT TWO LENSES FROM THE DIAGNOSTICS SET, PART NUMBER D9001-001, LOT NO. 011828 CAUSED A INTENSE DISCOMFORT ON TWO PATIENT'S EYES, WHICH REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGEYES, INC. DIAGNOSTIC A LENS SET SYNERGEYES, INC. DIAGNOSTIC A LENS SET LPL SYNERGEYES, INC. D9001-006 011828

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other