BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2502992 · Received March 22, 2012

    Report

    Report Number
    1644019-2012-00015
    Event Type
    Injury
    Date Received
    March 22, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FIBER, SUSPECTED FROM THE MAYO COVER, WAS OBSERVED INSIDE A PATIENT'S EYE POSTOPERATIVELY. THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO REMOVE THE FIBER. THE PATIENT IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1223352H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention