BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2003644 · Received February 24, 2011

    Report

    Report Number
    3003701944-2011-00005
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    OPTONOL, LTD.
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONAL INFO WAS REQUESTED VIA MAIL AND FAX 1/27/2011 AND BY PHONE ON 2/16/2011. CITATION: STEWART, R.M., DIAMOND, J.G., ASHMORE, E.D., AYYALA, R.S. (2005) COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION. AMERICAN JOURNAL OF OPHTHALMOLOGY 2005; 140:000-000, ELSEVIER, INC. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, "COMPLICATIONS FOLLOWING EX-PRESS GLAUCOMA SHUNT IMPLANTATION", PUBLISHED IN THE AMERICAN JOURNAL OF OPHTHALMOLOGY IN 2005 (ELSEVIER INC, 0002-9394/05), AN OPHTHALMOLOGIST REPORTED THAT A PT (CASE 4) WITH OPEN-ANGLE GLAUCOMA (CONTROLLED BY THREE DIFFERENT UNSPECIFIED MEDICATIONS) AND IMPLANTATION OF THIS SHUNT 18 MONTHS PRIOR TO THE VISIT, PRESENTED WITH PAIN (OD) FOR THREE DAYS. HIS VISUAL ACUITY WAS COUNTING FINGERS AND INTRAOCULAR PRESSURE (IOP) WAS 10 MM HG. CONJUNCTIVAL EROSION WITH EXPOSURE OF THE RIM OF THE SHUNT WAS NOTICED AT THE SUPERIOR LIMBUS. HYPOPYON AND VITRITIS (B-SCAN) LED TO A DIAGNOSIS OF (B)(6). THE SHUNT WAS REMOVED AND A VITRECTOMY WITH INTRAVITREAL ANTIBIOTICS WAS PERFORMED. THE ENDOPHTHALMITIS RESOLVED IN TWO WEEKS AND AT THE LAST FOLLOW-UP VISIT (3 MONTHS), THE PT'S IOP WAS 17 MM HG AND VISUAL ACUITY WAS HAND MOTIONS. THIS IS MDR # 4 OF 4 RELATED MDRS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention GLAUCOMA (UNSPECIFIED)| MEDICATIONS (3) FOR TREATMENT OF