BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI SURGICAL PROCEDURE PAK

    MDR report key: 6149014 · Received December 6, 2016

    Report

    Report Number
    1644019-2016-01508
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    February 14, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IN DEVICE EVALUATED BY MFR?, EVALUATION CODES AND ADDITIONAL MFR NARRATIVE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER; A DEVICE HISTORY REVIEW AND LOT HISTORY COULD NOT BE REVIEWED FOR THIS REPORT. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED "SMALL PIECES OF PLASTIC FROM TIP WRENCH ARE FREE AND ENTER THE EYE" DURING SURGERY. IT IS UNKNOWN IF ANY MATERIAL WAS RETAINED IN THE EYE AT THIS TIME. ADDITIONAL INFORMATION AND PRODUCT SAMPLE HAVE BEEN REQUESTED FOR THIS CASE. NO UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797715 INFINITI SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HANDPIECE| PHACO TIP| WRENCH