BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-OK OPHTHALMIC KNIVES

    MDR report key: 6127409 · Received November 25, 2016

    Report

    Report Number
    2523835-2016-00864
    Event Type
    Malfunction
    Date Received
    November 25, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 25, 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
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE 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 CUSTOMER REPORTED THAT MULTIPLE KNIVES WERE NOT SHARP ENOUGH AND REQUIRED EXTRA EFFORT IN ORDER TO MAKE THE INCISION DURING SEPARATE SURGERIES. THERE WAS NO IMPACT TO ANY PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778125 A-OK OPHTHALMIC KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 111884M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other