BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LABTICIAN, INC

    MDR report key: 381810 · Received March 13, 2002

    Report

    Report Number
    MW1024321
    Event Type
    Injury
    Date Received
    March 13, 2002
    Date of Event
    January 1, 2001
    Report Date
    March 13, 2002
    Manufacturer
    LABTICIAN OPHTHALMICS, INC
    Product Code
    HQJ
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL SUMMARY: THIS IS A PT TWO YEARS POST LEFT EYE SURGERY WITH PARS PLANITIS VITRECTOMY, SCLERAL BUCKLE, MEMBRANE PEELING AND EXTERNAL LASER IN 1999. THE PT WAS EXAMINED FOR STABILITY OF THE RETINAL ATTACHMENT STATUS AT 6 MONTHS, 12 MONTHS, AND 18 MONTHS THEREAFTER. ALL 3 EXAMS WERE UNREMARKABLE. IN 2001 THE PT BEGAN EXPERIENCING SEVERE, CONSTANT HEADACHES IN LEFT TEMPLE AT THE EYE SOCKET JUNCTURE AND DAILY LEFT EYE DISCHARGE MIXED WITH FRANK BLOOD. PT WAS SEEN IN 2002 ON CONSULTATION. AFTER 6 WEEKS PRESCRIPTION WITH PROPHYLACTIC CILOXAN EVERY DAY, CLINICAL ASSESSMENT REVEALED THAT THE SCLERAL BUCKLE IS WORKING ITS WAY OUT OF THE EYE TISSUE CAUSING LOW GRADE INFECTION AND HEADACHES. EARLY SURGERY FOR REMOVAL OF THIS DEVICE WAS STRONGLY INDICATED AND RECOMMENDED. PT WAS INFORMED THAT THE PROCEDURE CARRIES WITH IT THE RISK OF RE-DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LABTICIAN, INC SCLERAL BUCKLE HQJ LABTICIAN OPHTHALMICS, INC STYLE #276 12369
    2 LABTICIAN, INC SCLERAL BUCKLE HQJ LABTICIAN OPHTHALMICS, INC STYLE #240 12439
    3 LABTICIAN, INC SCLERAL BUCKLE HQJ LABTICIAN OPHTHALMICS, INC STYLE #270 13667

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention