BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KUGLEN LENS MANIPULATOR ANGLED ROUND

    MDR report key: 21904405 · Received April 24, 2025

    Report

    Report Number
    2242450-2025-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 24, 2025
    Manufacturer
    KATENA PRODUCTS INC.
    Product Code
    HND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    KATENA (CORZA) REACHED OUT TO THE REPORTER AND ATTEMPTED TO OBTAIN THE INSTRUMENT FOR EVALUATION, HOWEVER THE DEVICE COULD NOT BE RETRIEVED FROM THE FACILITY. REVIEW OF PICTURES SENT BY THE REPORTER INDICATES THAT THE PADDLE OF THE TIP OF THE INSTRUMENT IS MISSING. ADDITIONAL INFORMATION PROVIDED BY THE REPORTER INDICATES THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS FOUND TO BE IN GOOD CONDITION. AN UPDATE ON THE PATIENT'S CONDITION WAS REQUESTED TO WHICH THE REPORTER RESPONDED THAT THE RETAINED FOREIGN BODY HAS NO IMPACT ON THE PATIENT'S VISION AND THAT THE PATIENT'S VISION IS "NORMAL" POST SURGERY. REPORTER IS NOT ABLE TO DETERMINE THE PURCHASE DATE OF THE INSTRUMENT AND WITH NO LOT PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE AGE OF THE INSTRUMENT OR THE AMOUNT OF TIME IT HAS BEEN ON THE FIELD. HISTORICAL COMPLAINT DATA WAS REVIEWED FOR K3-5523 AND KATENA WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AGAINST THIS PRODUCT.

    Description of Event or Problem · 0

    ON 26-MAR-2025, KATENA PRODUCTS INC. (A CORZA MEDICAL COMPANY) RECEIVED NOTIFICATION THAT A MEDWATCH REPORT (MW5167683) FROM THE FDA STATING THAT K3-5523 KUGLEN LENS MANIPULATOR BROKE WHILE MANIPULATING THE LENS DURING CATARACT SURGERY ON (B)(6) 2025. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN TIP OF THE INSTRUMENT FROM THE PATIENT'S EYE BUT WAS UNSUCCESSFUL. THE SURGEON DETERMINED THAT THE RISK OF CONTINUING TO ATTEMPT THE RETRIEVAL WAS TOO GREAT SO THE FOREIGN OBJECT WAS LEFT IN THE EYE. BASED ON ASSESSMENT BY THE SURGEON, CONTINUED ATTEMPTS COULD RESULT IN INJURY TO THE EYE. THE PATIENT HAS SINCE RECOVERED AND DOING WELL. UPON RECEIPT OF THIS NOTIFICATION, KATENA STARTED THE COMPLAINT INVESTIGATION OF THIS EVENT. NO LOT NUMBER WAS PROVIDED. KATENA ATTEMPTED TO RETRIEVE THE BROKEN INSTRUMENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226338 KUGLEN LENS MANIPULATOR ANGLED ROUND Spatula, ophthalmic HND KATENA PRODUCTS INC. K3-5523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown