BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES, INC. HYBRID CONTACT LENS M

    MDR report key: 2083399 · Received March 31, 2011

    Report

    Report Number
    3005087645-2011-00002
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 31, 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 NO DEFECT PRESENT ON THE LENS AFTER SURFACE INSPECTION OF THE RETURNED LENS.

    Description of Event or Problem · 1

    FROM A LETTER FROM THE PRACTICE ON (B)(6) 2011: "I AM RETURNING CONTACT LENS FOR OUR PATIENT (B)(6), ORDERED ON (B)(6) 2010, UNDER ORDER # (B)(4) AND SHIPMENT WAS RECEIVED ON (B)(6) 2010. DUE TO PATIENT'S BUSY WORK SCHEDULE, PATIENT WAS FITTED WITH CONTACT LENSES ON (B)(6) 2010. AFTER NUMEROUS CONTACT LENS FOLLOW-UP VISITS, DR (B)(6) MADE SEVERAL RX CHANGES FOR OS (LEFT) CONTACT LENS ONLY PATIENT CONTINUED TO WEAR OD (RIGHT) LENS FOR THE TIME PERIOD. AFTER NUMEROUS CONTACT LENS FOLLOW-UP VISITS FROM (B)(6) 2010 THROUGH (B)(6) 2011, DR (B)(6) FOUND THAT OS (LEFT) LENS WAS STILL NOT A SUCCESSFUL FIT. ON (B)(6) 2011, PATIENT TELEPHONED OUR OFFICE AND INFORMED US THAT OS (LEFT) WAS FEELING UNCOMFORTABLE AND CONSTANTLY WATERY AND COMPLAINED OF EXCESS DISCOMFORT, BUT OD (RIGHT) LENS WAS DOING FINE. DR (B)(6) SEEN PATIENT IN (B)(6) 2011, AND DIAGNOSED HER WITH (OS) CORNEAL ULCER/ABRASION AND WAS PRESCRIBED TOBRADEX ST EYE DROPS, PATIENT WAS SCHEDULED TO RETURN FOR A FOLLOW-UP VISIT ON (B)(6) 2011. AT PATIENT'S FOLLOW-UP VISIT, DR (B)(6) DIAGNOSED PATIENT WITH EPITHELIAL BASEMENT MEMBRANE DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGEYES, INC. HYBRID CONTACT LENS M CONTACT LENS HQD SYNERGEYES, INC. M-MULTI-FOCAL 027748

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention