BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIL. COATED I/A 45° MILL

    MDR report key: 12706449 · Received October 27, 2021

    Report

    Report Number
    0001920664-2021-00142
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BAUSCH + LOMB GMBH
    Product Code
    HNN
    PMA / PMN Number
    K073023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION HAS BEEN COMPLETED. ONE OPENED 85910S I/A HANDPIECE FROM LOT FS21037856 WAS RETURNED. THE EXPIRATION DATE ON THE LABEL IS 2024-02. VISUAL INSPECTION FOUND PARTICULATES AND DRIED SOLUTIONS VISIBLE ON THE IRRIGATION SLEEVE. MICROSCOPIC EXAMINATION WAS PERFORMED AND FOUND NO DEFECTS THAT WOULD CAUSE EXPOSURE TO A SHARP EDGE. A FUNCTIONAL TEST WAS PERFORMED AND FOUND THAT THE ASSEMBLY PERFORMED AS INTENDED. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. CAPSULE RAPTURE IS A WELL-KNOWN RISK OF THE SURGERY. USE OF AN INSTRUMENT WITH A SILICONE SLEEVE REDUCES THIS RISK BUT DOES NOT COMPLETELY ELIMINATE IT. IN LAST 2 YEARS THIS IS THE ONLY RECORDED CASE OF CAPSULE DAMAGE FOR OVER 1,6 MLN UNITS WITH A SILICONE, SOLD BY BAUSCH AND LOMB IN LAST 2 YEARS. THE SURGEON PLACED A THREE PIECE LENS IN THE PATIENT AND THE PATIENT IS DOING WELL.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DEVIATIONS OR ISSUES WERE FOUND. THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THIS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE SURGEON REPORTED WHILE POLISHING THE IA TIP BROKE THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601873 SIL. COATED I/A 45° MILL HANDHELD SURGICAL INSTRUMENT HNN BAUSCH + LOMB GMBH 85910S 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention