BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2465191 · Received February 21, 2012

    Report

    Report Number
    3002037047-2012-00036
    Event Type
    Injury
    Date Received
    February 21, 2012
    Report Date
    January 22, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. ALTHOUGH THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNK, ACTIONS HAVE BEEN TAKEN TO THE MANUFACTURING PROCESS TO REDUCE PROCESS VARIABILITY AND IMPROVED INSPECTION METHODS HAVE BEEN ADDED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE BLADES INCLUDED IN THE PACKS HAVE POOR CUTTING PERFORMANCE. THE SURGEON REPORTED HAVING TO USE FORCE TO CREATE THE INCISION. WHEN THE KNIFE SUDDENLY ENTERED THE EYE, THE RHEXIS WAS TORN, BUT WAS MANAGED BY THE SURGEON DURING THE PROCEDURE. IN ORDER TO THEN ENTER THE INCISION, THE SURGEON HAD TO "MOVE THE KNIFE" LEADING TO AN INCREASED INCISION SIZE, A LOSS OF ACCURACY, AND A RESISTANCE TO THE ENTRY OF THE CARTRIDGE FOR INTRAOCULAR LENS (IOL) IMPLANTATION. THE PROCEDURES WERE COMPLETED WITH NO POSTOPERATIVE CONSEQUENCES TO THE PTS.

    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 CLEARCUT HP2 DB SLIT 2.2MM