BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 5079453 · Received September 15, 2015

    Report

    Report Number
    2523835-2015-00839
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Report Date
    January 11, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    KYG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE CUSTOMER DID NOT PROVIDE A SAMPLE FOR EVALUATION. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A LOT HISTORY AND COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED. PHOTOGRAPHS WERE SUPPLIED BY THE CUSTOMER WHICH ARE OBSERVED TO BE AT A SIGNIFICANTLY HIGHER MAGNIFICATION THAN THE PRODUCT SPECIFICATIONS. A CROSS FUNCTIONAL TEAM OF MANUFACTURING, QUALITY AND ENGINEERING REVIEWED THIS COMPLAINT AND DETERMINED THAT THE PHOTOGRAPHY DID NOT DEMONSTRATE AN OUT OF SPECIFICATION CONDITION FOR THE PRODUCT. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION IS AVAILABLE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THROUGH MICROSCOPY EVALUATION OF THE IA TIPS, TEARS WERE OBSERVED IN THE SILICONE SLEEVES. THE TEARS WERE OBSERVED AFTER TEN USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609617 SILICONE IRRIGATION AND ASPIRATION TIPS DEVICE, IRRIGATION, OCULAR SURGERY KYG ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other