BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID CONTACT KC LENS

    MDR report key: 2251132 · Received September 2, 2011

    Report

    Report Number
    3005087645-2011-00004
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 31, 2011
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS HAS BEEN RETURNED TO THE COMPANY. THE BASE CURVE AND SURFACE INSPECTION WAS FOUND TO BE WITHIN SPECS OF THE LABELED PART NUMBER.

    Description of Event or Problem · 1

    FROM THE PRODUCT RETURN FORM: "CAUSING PAIN/REDNESS" A COMPLAINT FOLLOW-UP FORM WAS FAXED TO THE PRACTICE TO OBTAIN MORE INFO. FROM THE COMPLETED COMPLAINT FOLLOW-UP FORM RECEIVED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRID CONTACT KC LENS CONTACT LENS HQD SYNERGEYES, INC. KC 036888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention