BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 2032386 · Received March 25, 2011

    Report

    Report Number
    3003701944-2011-00012
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 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
    NY, 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO OPTONOL'S ACCEPTANCE CRITERIA. THE STERILE PACKAGE AND STERILIZATION CYCLE WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ROOT CAUSE FOR THE ENDOPHTHALMITIS CANNOT BE DETERMINED. ADD'L INFO WAS REQUESTED VIA PHONE ON 02/25/2011, 02/28/2011, 03/22/2011; VIA FAX ON 03/04/2011 AND 03/22/2011; VIA MAIL ON 03/04/2011. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/25/2011. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED TWO CASES OF ENDOPHTHALMITIS FOLLOWING SURGERY. HE NOTED THIS PT HAD A DUAL SURGERY FOR CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT AND SHUNT IMPLANT. HE STATED THE PT PRESENTED WITH GROSSLY EXAGGERATED POST-OPERATIVE INFLAMMATION IN THE OPERATED EYE ON (B)(6) 2011. HE REPORTED THE POST-OPERATIVE REGIMEN CONSISTED OF STEROID DROPS, ORAL AND OCULAR ANTIBIOTICS, CYCLOPLEGIC DROPS, AND VITREOUS ANTIBIOTICS 3 DAYS POST-OP. HE STATED THE PT WAS LAST SEEN ON (B)(6) 2011 AND THE INFLAMMATION APPEARED STAGNANT AND HAD NOT PROGRESSED. HE NOTED FOR THIS REASON CULTURES WERE NOT PERFORMED. AT THIS TIME HE REPORTED THE PT WAS GOING IN THE RIGHT DIRECTION. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS REPORT; THIS REPORT IS FOR THE FIRST PT.

    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 102711

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 25 GAUGE NEEDLE (BRAND INFO UNK)| INTRAOCULAR LENS (BRAND INFO UNK)