BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1230803 · Received November 6, 2008

    Report

    Report Number
    2523835-2008-00006
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING QA NOTIFIED. COMPLAINT NOT CONFIRMED BECAUSE NO SAMPLES WERE RETURNED AND NO LOT NUMBER WAS PROVIDED. NO CORRECTIVE ACTION TAKEN. THIS REPORT WAS MAILED TO FDA ON: 11/06/2008.

    Description of Event or Problem · 1

    SURGEON REPORTED THE BLADES ARE NOT 3.0MM; REPORTS NEEDING TO FREQUENTLY ENLARGE THE INCISION TO INSERT AMO LENS. ADDITIONAL INFORMATION WAS RECEIVED ON 10/08/2008. THE SURGEON INDICATED THAT ALL PATIENT OUTCOMES WERE GOOD AND NO VISUAL DISTURBANCE OR LONG TERM COMPLICATION RESULTED. THE SURGEON STATED THAT NO PATIENT IDENTIFIERS / INFORMATION WOULD BE PROVIDED. THE SURGEON STATED THAT HER PRIMARY CONCERN IS THAT THE KNIFE SHARPNESS IS NOT ALWAYS CONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065983065 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1