BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2161834 · Received July 8, 2011

    Report

    Report Number
    3003701944-2011-00021
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO OPTONOL'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE FOR THE CLOGGED SHUNT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. A POSSIBLE CAUSE FOR A CLOGGED SHUNT IS THAT THE LUMEN BECOMES BLOCKED. HOWEVER, IT IS UNLIKELY THAT A BLOCKED LUMEN OCCURRED DURING THE MANUFACTURING PROCESS. SOME POTENTIAL CAUSES COULD BE MISPLACED SHUNT DURING IMPLANTATION, TISSUE RESIDUES FROM SURGERY, OR BLOOD CLOTS FROM SURGERY. ADDITIONAL INFORMATION WAS REQUESTED FROM THE OPHTHALMIC SURGEON BY PHONE ON (B)(6) 2011, BY MAIL ON (B)(6) 2011 AND (B)(6) 2011. ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPHTHALMIC SURGEON ON (B)(6) 2011 AND (B)(6) 2011. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    AN OPTHALMIC SURGEON INITIALLY REPORTED A PATIENT'S INTRAOCULAR PRESSURE (IOP) DID NOT DECREASE ONE WEEK AFTER IMPLANTATION OF THIS DEVICE IN THE RIGHT EYE (OD) AND THE IOP REMAINED THE SAME AS PRIOR TO SURGERY (17 MMHG). ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON ON (B)(6) 2011, STATING THAT THE SHUNT DID NOT SPONTANEOUSLY FILTER AND WAS CLOGGED. HE REPORTED THE PATIENT'S IOP WAS 18 MMHG POSTOPERATIVELY AFTER TREATMENT WITH A GLAUCOMA MEDICATION AND 32 MMHG AFTER TREATMENT WITH AN ADDITIONAL GLAUCOMA MEDICATION. THE SURGEON INDICATED THAT THE DEVICE HAD NOT YET BEEN EXCISED AND ANOTHER PROCEDURE WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 104725

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 9-0 VICRYL SUTURE (OD)| MITOMYCIN (OD)| UNSPECIFIED MEICATIONS