BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPEREAGLE PUNCTUM PLUG

    MDR report key: 791419 · Received November 30, 2006

    Report

    Report Number
    1034718-2006-00026
    Event Type
    Other
    Date Received
    November 30, 2006
    Date of Event
    May 3, 2006
    Report Date
    November 29, 2006
    Manufacturer
    EAGLE VISION, INC.
    Product Code
    LZU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUNCTUM PLUG REPORTEDLY EXTRUDED ON ITS OWN. AN EXAM FOLLOWING EXTRUSION REVEALED A GRANULOMA PROTRUDING FROM THE PUNCTAL OPENING ABOUT 1.5 TO 2.0MM IN LENGTH. NO MEDICATIONS WERE PRESCRIBED. THE PATIENT PRESENTED 3 MONTHS LATER AND THE PUNCTUM APPEARED COMPLETELY NORMAL WITH NO EVIDENCE OF THE GRANULOMA. NO ADDITIONAL INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    ON NOVEMBER 21, 2006, THE FOLLOWING REPORT WAS RECEIVED BY EAGLE VISION, INC. THE PATIENT WAS SEEN FOR INSERTION. THIS WAS AFTER THE ORIGINAL CIBA TEARSAVER .5MM FELL OUT. I INSERTED A MEDIUM SUPER EAGLE REF. 3131, LOT 73394 IN THE LEFT EYE. SHE RETURNED 47 DAYS LATER FOR A FOLLOW-UP AND THE PATIENT STATED THAT SHE THOUGHT THE PLUG FELL OUT. EXAM REVEALED A GRANULOMA PROTRUDING FROM THE OPENING ABOUT 1.5 TO 2.0MM IN LENGTH. SHE RETURNED 3 MONTHS LATER AND THE PUNCTUM APPEARED COMPLETELY NORMAL WITH NO EVIDENCE OF THE PREVIOUS GRANULOMA. NO MEDS WERE PRESCRIBED IN THIS CASE. THE AGE OF THE PATIENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPEREAGLE PUNCTUM PLUG PUNCTUM PLUG LZU EAGLE VISION, INC. NA 73394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other