BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1993687 · Received February 11, 2011

    Report

    Report Number
    1644019-2011-00005
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    December 26, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ALCON -HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR A ONE YEAR PERIOD; THIS IS THE FIRST EVENT REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. THERE ARE NO ADD'L REPORTS AGAINST THIS FINISHED GOODS LOT. THE PAK WAS BUILT PER SPECS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS INVESTIGATION. THE FACILITY STATED THAT IT IS "NOT INDICATING THE PRODUCT INVOLVED AND THAT THIS REPORT IS FOR INFO ONLY". THE STERILIZATION BATCH RECORDS WERE REVIEWED BY STERILITY ASSURANCE AND NO ISSUES/DEVIATIONS WERE NOTED AND THE PRODUCT WAS RELEASED PER SPECS. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS DIAGNOSED WITH ENDOPHTHALMITIS SIX DAYS FOLLOWING A CATARACT EXTRACTION WITH LENS IMPLANT SURGERY. CULTURES WERE PERFORMED. NO OTHER INFO IS AVAILABLE AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON -HOUSTON CUSTOM PAK 1083050H

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention DUOVISC| BSS