BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3523044 · Received December 4, 2013

    Report

    Report Number
    3003701944-2013-00117
    Event Type
    Injury
    Date Received
    December 4, 2013
    Report Date
    November 5, 2013
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER OR SERIAL NUMBER WERE INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. GROVER, D.S. FELLMAN, M.A., & FELLMAN, R.L. (2013). NEW AB INTERNO TECHNIQUE FOR REMOVAL OF IRIS - EMBEDDED EX-PRESS SHUNT AND CHRONIC EYE PAIN CAUSED BY SHUNT MALPOSITIONING. THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 131(10). DOI:10.1001/JAMAOPHTHALMOL.2013.4274. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, THE AUTHOR REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE, A PT DEVELOPED A TENON CYST. THE TENON CYST WAS REFRACTORY TO TWO SESSIONS OF BLEB NEEDLING WITH AN ANTIFIBROTIC TREATMENT. HER INTRAOCULAR PRESSURE WAS 24MM HG WITH MAXIMAL MEDICAL THERAPY. AN AB INTERNO TRABECULECTOMY WAS PERFORMED AND THE NONFUNCTIONING GFD WAS REMOVED AT THE SAME TIME VIA THE AB INTERNO APPROACH. THE TENON CYST IS STILL PRESENT AND HER EXAMINATION FINDINGS WERE OTHERWISE STABLE. THE PURPOSE OF THE ARTICLE WAS TO DESCRIBE A NEW AB INTERNO TECHNIQUE FOR REMOVAL OF A GFD THAT IS MORE EFFICIENT AND LESS TRAUMATIC. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628704 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention ACETAZOLAMIDE| DORZOLAMIDE TIMOLOL| LATANOPROST| MITOMYCIN C| BRIMONIDINE