BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M HYBRID CONTACT LENS

    MDR report key: 2853169 · Received July 9, 2008

    Report

    Report Number
    3005087645-2008-00002
    Event Type
    Injury
    Date Received
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE DOCTOR STATED A CORNEAL ULCER DEVELOPED IN THE RIGHT EYE LESS THAN 2 DAYS THESE LENSES WERE DISPENSED, AND THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGIST. DR (B)(6) FILLED OUT A COMPLAINT FOLLOW-UP FORM TO DESCRIBE THE EVENT. HE WROTE "AFTER 1 DAY WEARING NEW SYNERGEYES, INC. MULTI-FOCAL PATIENT DEVELOPED SEVERE STROMAL EDEMA WHICH LEAD TO CORNEAL ULCER, OD. MEDICAL INTERVENTIONS WAS REQUIRED. ON (B)(6) 2008, THE EVENT HAD NOT RESOLVED. DR (B)(6) COMPLETED ANOTHER COMPLAINT FOLLOW-UP FORM TO DESCRIBE THE EVENT ON (B)(6) 2008. HE WROTE "CORNEAL ULCER OD WITH STROMAL EDEMA AFTER 1 DAY WEAR." THE PATIENT'S RECOVERY WAS STATED AS "90% RESOLVED BY (B)(6) 2008."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. AM7588+0075+022519 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention