BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2924830 · Received January 17, 2013

    Report

    Report Number
    3003701944-2013-00004
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 18, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED. NO DATA REGARDING IDENTITY WAS RECEIVED, I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DFR) COULD NOT BE REVIEWED. NO SAMPLE WAS RETURNED; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE ROOT CAUSE CANNOT BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT IN HIS LAST TWO GLAUCOMA SHUNT INSERTIONS, HE HAD SIGNIFICANT DIFFICULTY RELEASING THE SHUNT FROM THE INSERTER DEVICE. THE SURGEON REPORTED HE HAD NEVER EXPERIENCED THIS PROBLEM BEFORE. FOR THIS PT, THE SURGEON REPORTED HE ALMOST HAD TO REMOVE THE SHUNT AND CONVERT TO A TRABECULECTOMY BECAUSE HE WAS HAVING DIFFICULTY GETTING THE SHUNT TO RELEASE. AFTER MUCH MANIPULATION AND PULLING WITH FORCEPS, HE WAS ABLE TO RELEASE THE SHUNT. THE SURGEON REPORTED THE PT'S ANTERIOR CHAMBER WAS ALMOST COMPLETELY FLAT. THE SURGEON REPORTED THE PT WAS DOING FINE NOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26236 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other