BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ DECEMET KELLY MEMBRANE PUNCH

    MDR report key: 2542964 · Received April 11, 2012

    Report

    Report Number
    1920664-2012-00060
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED VIA VOLUNTARY REPORT (B)(4). THE USER FACILITY REPORTED THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED, SHOULD ADDITIONAL INFORMATION BE RECEIVED OR THE DEVICE BECOME AVAILABLE FOR INVESTIGATION. CORRECTION TO VOLUNTARY USER FACILITY REPORT: (B)(4). THE KELLY PUNCH WAS IDENTIFIED AS SERIAL NUMBER (B)(4); HOWEVER, THE NUMBER DOES NOT CORRESPOND TO BAUSCH & LOMB KELLY PUNCH INSTRUMENTS. THE CORRECT NUMBER HAS BEEN PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    A REPORT FROM THE USER FACILITY REPORTED "AN (B)(6) FEMALE UNDERWENT A TRABECULECTOMY WITH MITOMYCIN-C TO HER RIGHT EYE AND PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION WITH THE USE OF MALYUGIN IN THE RIGHT EYE ON (B)(6) 2012. INTRAOPERATIVELY, THE KELLY PUNCH BROKE AT 2.5 MM OF THE TIP FRAGMENT WAS RETRIEVED FROM THE PT'S RIGHT EYE FLAP". THE PT WAS DISCHARGED FROM THE HOSPITAL; HOWEVER, THE PT'S OUTCOME, THOUGH REQUESTED, HAS NOT BEEN SUPPLIED BY THE USER FACILITY TO BAUSCH & LOMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ DECEMET KELLY MEMBRANE PUNCH DECEMET KELLY MEMBRANE PUNCH HNJ BAUSCH & LOMB, INC. E2798

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention