BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON SURGICAL KNIFE/BLADE

    MDR report key: 6205229 · Received December 27, 2016

    Report

    Report Number
    2523835-2016-00948
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Report Date
    December 27, 2016
    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
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT MULTIPLE KNIVES HAVE LEFT METALLIC PARTICLES IN THE CORNEAL STROMA DURING SEPARATE SURGERIES WHILE SOME OF THE KNIFE BLADES WERE ALSO DULL. ALTERNATE KNIVES WERE OBTAINED IN ORDER TO CONTINUE EACH PROCEDURE IN WHICH THE DULL KNIFE WAS EXPERIENCED. PATIENT IMPACT INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856270 ALCON SURGICAL KNIFE/BLADE KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other