BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-OK OPHTHALMIC KNIVES

    MDR report key: 6146245 · Received December 5, 2016

    Report

    Report Number
    2523835-2016-00900
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 21, 2016
    Report Date
    April 24, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. A REVIEW OF THE RELATED DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER HAS BEEN PERFORMED AND NO ANOMALIES WERE FOUND. THE PRODUCT WAS RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THAT THREE ADDITIONAL COMPLAINTS HAVE BEEN ASSOCIATED WITH THE REPORTED LOT NUMBER FOR THE REPORTED COMPLAINT ISSUE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ONE OPENED KNIFE SAMPLE WAS RECEIVED BY MANUFACTURING WITH A FOAM BLADE PROTECTOR, SEATED CORRECTLY IN THE PACKAGE TRAY, FOR THE REPORT OF BEING DULL. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AND WAS FOUND TO BE CONFORMING. PENETRATION TESTING WAS THEN PERFORMED AND WAS FOUND TO BE NONCONFORMING. A REVIEW OF THE DEVICE HISTORY RECORD RELATED TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THAT THERE ARE 15 ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT FOR THE REPORTED ISSUE. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION PERFORMED. POSSIBLE ROOT CAUSES RELATED TO THE MANUFACTURING PROCESS OF THE KNIVES HAVE BEEN IDENTIFIED. THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE SAMPLE IS UNKNOWN. AN INVESTIGATION HAS BEEN INITIATED TO INVESTIGATE THE POSSIBLE MANUFACTURING RELATED ROOT CAUSE AND NUMBER OF RELATED COMPLAINTS FOR THIS ISSUE. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY NONCONFORMANCE IS REMOVED FROM THE LOT AND SCRAPPED. FUNCTIONAL PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A KNIFE WAS TOO DULL TO MAKE THE PARACENTESIS DURING CATARACT SURGERY. AN ALTERNATE KNIFE HAD TO BE OBTAINED IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794899 A-OK OPHTHALMIC KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 147174M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other