BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGYEYES CONTACT LENS

    MDR report key: 3173423 · Received May 10, 2013

    Report

    Report Number
    3005087645-2013-00001
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: CONTACT LENS WAS MEASURED FOR BASE CURVE AND POWER. RESULTS: SURFACE INSPECTION DETERMINED THAT THERE WAS A TEAR IN THE LENS. BASE CURVE AND POWER MATCHED THE VIAL LABEL. CONCLUSION: THERE IS NOT A CLEAR CONCLUSION ABOUT WHERE THE TEAR OCCURRED. THIS TYPE OF TEAR CAN BE CAUSED BY PT MISHANDLING OF THE CONTACT LENS OR IN THE MFG PROCESS.

    Description of Event or Problem · 1

    PT WAS SEEN BY THE PRACTITIONER ON (B)(6) 2013 FOR RED AND IRRITATED EYES. THE PRACTITIONER'S EXAMINATION DETERMINED THAT THE PT'S OD CORNEAL WAS ABRADED AND AFFECTED THE EYE NEAR THE LIMBUS. THE PT WAS TREATED IN THE PRACTITIONER'S OFFICE WITH CYCLOPLEGIA AND ANTIBIOTICS. THE PT WAS RELEASED AFTER TREATMENT. THE PRACTITIONER STATED THAT THE CONTACT LENS SEPARATED (TEAR) AND CAUSED THE CORNEAL ABRASION. SYNERGYEYES WAS MADE AWARE OF THE EVENT ON (B)(4) 2013 WHEN THE CONTACT LENS AND COMPLAINT FORM WAS RETURNED TO SYNERGYEYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209479 SYNERGYEYES CONTACT LENS CLEARKONE CONTACT LENS HQD SYNERGEYES, INC. CLEARKONE 047369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention