BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2484631 · Received March 7, 2012

    Report

    Report Number
    3002037047-2012-00039
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLACE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED FIBERS WERE OBSERVED INSIDE PTS' EYES FOLLOWING SURGERY. A SECONDARY PROCEDURE IS PLANNED TO REMOVED THE FIBER(S). ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other