BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-PAK SURGICAL PROCEDURE PACK

    MDR report key: 6067842 · Received October 31, 2016

    Report

    Report Number
    1644019-2016-01385
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 28, 2016
    Report Date
    January 17, 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
    FL, 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

    A DEVICE HISTORY RECORD REVIEW SHOWS THAT THE PRODUCT LOT SPECIFIC TO THIS EVENT WAS BUILT TO SPECIFICATION. THE DRAWING FOR THIS PACK WAS REVIEWED AND THE DRAPES, MAYO STAND COVER, SPONGE GAUZE, TOWELS, GOWNS, COTTON TIP APPLICATORS, EYE SPEARS, EYE PAD, INSTRUMENT WIPE, LABELS, PREP WRAP, AND BACK TABLE COVER WERE IDENTIFIED AS PACK COMPONENTS THAT COULD CONTRIBUTE TO LINT AND FIBERS. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LINT IN AN UNSPECIFIED QUANTITY OF EYE SURGERIES. IT IS UNKNOWN IF THE LINT WAS RETAINED IN THE EYES POST OPERATIVELY. ADDITIONAL INFORMATION AND PRODUCT SAMPLE WAS REQUESTED. NO UPDATES HAVE BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719356 CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - HOUSTON NA 1924127H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other