BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE PIECE ULTRAFLOW SERIES

    MDR report key: 12291841 · Received August 6, 2021

    Report

    Report Number
    2523835-2021-00295
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 13, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    GBX
    UDI-DI
    00380658170011
    PMA / PMN Number
    K910245
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTRA IRRIGATION ASPIRATION(IA) TIP WAS RECEIVED FOR EVALUATION. A VISUAL ASSESSMENT OF THE RETURNED SAMPLE FOUND TO HAVE A DIG ON THE TIP, NO BURR WAS OBSERVED. HOW OR WHEN THIS NONCONFORMITY OCCURRED REMAINS INCONCLUSIVE. NO FUNCTIONAL TESTING WAS ABLE TO BE PERFORMED. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DETERMINED CONCLUSIVELY. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY THE IRRIGATION/ASPIRATION(I/A) TIP A I/A HANDPIECE WAS FOUND TO HAVE A BURR. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT POSTERIOR CUT HAPPENED WHILE CORTICAL CLEANING. THE INTRAOCULAR LENS(IOL) WAS PLACED TO TAMPONADE THE HOLE IN POSTERIOR CAPSULE. THERE WAS NO VITREOUS PRESENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187723 SINGLE PIECE ULTRAFLOW SERIES CATHETER, IRRIGATION GBX ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU 00380658170011

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other