BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOELASTIC CANNULA

    MDR report key: 18705341 · Received February 14, 2024

    Report

    Report Number
    0001920664-2024-70023
    Event Type
    Injury
    Date Received
    February 14, 2024
    Report Date
    January 29, 2024
    Manufacturer
    STERIMEDIX LIMITED
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR RETURN. AT THIS TIME, NO REMEDIAL, CORRECTIVE, PREVENTIVE OR FIELD SAFETY CORRECTIVE ACTION IS REQUIRED. THE INVESTIGATION OF THE EVENT IS ONGOING.

    Additional Manufacturer Narrative · 0

    OWING TO VERY LIMITED INFORMATION PROVIDED BY THE CUSTOMER ALONG WITH NO SAMPLE TO INSPECT, WE ARE UNABLE TO IDENTIFY THE ACTUAL ROOT CAUSE. POTENTIAL ROOT CAUSE: WHEN CONSIDERING THE MATERIALS USED AND THE PROCESSES DURING MANUFACTURING (BOTH AT THE SUPPLIER AND STERIMEDIX), IT IS HIGHLY UNLIKELY THAT OUR PRODUCT CONTRIBUTED TO THE NON-CONFORMANCE REPORTED. IT IS MORE LIKELY THAT OTHER PRODUCTS OR DEVICES USED IN THE PROCEDURE EITHER CONTRIBUTED OR WERE SOLELY RESPONSIBLE FOR THE CONTAMINATION PASSING THROUGH INTO THE PATIENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PARTICLES/THREADS WERE IDENTIFIED IN THE PATIENT'S EYE DURING PRODUCT ADMINISTRATION WHILE USING THE CANNULA. SOME DAYS AFTER LENS IMPLANTATION, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE THREAD AS IT WAS IN THE PATIENT'S VIEWING FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430664 VISCOELASTIC CANNULA CANNULA, OPHTHALMIC HMX STERIMEDIX LIMITED M3926A 430605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BTG SYRINGE