BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES, INC., HYBRID CONTACT LENS A

    MDR report key: 2031960 · Received February 11, 2011

    Report

    Report Number
    3005087645-2011-00001
    Event Type
    Injury
    Date Received
    February 11, 2011
    Report Date
    February 7, 2011
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K051035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS HAD PASSABLE DEFECT (SCRATCH) ON THE LENS. IN REVIEW OF THE DEVICE HISTORY RECORD, THE FINAL INSPECTOR MADE NO MENTION OF ANY SCRATCHES PRESENT ON THE LENS. DEFECT COULD HAVE BEEN CAUSED BY THE USER DURING USAGE OF THE DEVICE.

    Description of Event or Problem · 1

    FROM THE PRODUCT RETURN FORM REC'D ON (B)(6), 2011: "PT DEVELOPED AN ULCER IN OS. OPENED UP SECOND PACKET DOING FINE IN THE LENS." FROM THE COMPLAINT F/U FORM REC'D (B)(6), 2011: "WERE ON LEFT EYE AFTER WEAR OF SYNERGEYES, INC. LENSES." PT REQUIRED MEDICAL INTERVENTION. YES, VIGAMAX USED. MEDICAL ATTENTION/INTERVENTION WAS REQUIRED TO PREVENT VISUAL IMPAIRMENT OR PERMANENT DAMAGE TO THE EYE. THERE WAS 100% RESOLUTION OF THE EVENT. THE PRACTITIONER STATED THAT "YES, WITH A SCAR LEFT ON THE CORNEA." THE PRACTITIONER FURTHER STATED THAT "I ORDERED A REPLACEMENT. SHE HAS BEEN WEARING ANOTHER LENS OF SAME PARAMETER WITH NO PROBLEM, SO MUST HAVE BEEN A DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGEYES, INC., HYBRID CONTACT LENS A CONTACT LENS HQD SYNERGEYES, INC. A-AMETROPIA 030941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention