BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANI OPHTHALMIC KNIFE

    MDR report key: 23846394 · Received December 18, 2025

    Report

    Report Number
    3002692886-2025-00007
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 19, 2025
    Manufacturer
    MANI HANOI CO.LTD
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION METHOD: ANALYSIS OF MANUFACTURING RECORDS; CONFIRMATION OF STORED SAMPLES; IMAGE ANALYSIS PROVIDED BY THE HEALTHCARE FACILITY. INVESTIGATION RESULT AND CONCLUSION: NO MALFUNCTION OR ISSUE WAS IDENTIFIED IN THE DEVICE. INVESTIGATION SUMMARY: IT WAS CONFIRMED THAT THE HOSPITAL DID NOT SEND THE OPHTHALMIC KNIFE OR THE FOREIGN MATERIAL ALLEGED TO HAVE BEEN MIXED IN, AND ONLY PROVIDED AN IMAGE WITH UNKNOWN MAGNIFICATION. FROM THE IMAGE, THE FOREIGN MATERIAL APPEARS TO BE A THIN, THREAD-LIKE OBJECT (SILVER, SEMI-TRANSPARENT, OR WHITE). SINCE THE CORNERS AND BENDS SEEM TO MAINTAIN THEIR SHAPE, IT IS PRESUMED TO HAVE A CERTAIN DEGREE OF HARDNESS. THE LENGTH OF THE FOREIGN MATERIAL IS ESTIMATED TO BE IN THE RANGE OF 2.4 MM TO 4.8 MM, AND THE WIDTH IN THE RANGE OF 0.05 MM TO 0.10 MM. SIX RETAINED SAMPLES FROM THE SAME LOT WERE OPENED AND EXAMINED, AND NO FACTORS THAT COULD LEAD TO THE OCCURRENCE OF FOREIGN MATERIAL SIMILAR TO THAT SHOWN IN THE PROVIDED IMAGE WERE IDENTIFIED. IN ADDITION, THE MANUFACTURING RECORDS OF THE COMPLAINT LOT WERE REVIEWED, AND THE DEFECT RATE AND FOREIGN MATERIAL OCCURRENCE RATE DURING THE MANUFACTURING PROCESS WERE INVESTIGATED. NO ABNORMALITIES WERE FOUND. BASED ON THESE FINDINGS, IT IS INFERRED THAT THE PRODUCT WAS IN GOOD CONDITION AT THE TIME OF SHIPMENT. FURTHERMORE, SINCE IT HAS BEEN CONFIRMED THAT THE COMPLAINT PRODUCT AND THE FOREIGN MATERIAL WILL NOT BE RETURNED, AND NO DETAILED INFORMATION REGARDING THE SURGICAL PROCEDURE HAS BEEN OBTAINED AT THIS TIME, FURTHER DETAILED ANALYSIS, CONSIDERATION, OR CONCLUSION IS NOT FEASIBLE.

    Description of Event or Problem · 0

    ON (B)(6), WE RECEIVED THE FOLLOWING INFORMATION FROM THE SALES AGENT IN FRANCE: "REGARDING A PATIENT WHO UNDERWENT CATARACT SURGERY ON THE AFTERNOON OF (B)(6), AN EMERGENCY REOPERATION WAS PERFORMED THIS MORNING DUE TO POSTOPERATIVE COMPLICATIONS. THE CAUSE WAS THE PRESENCE OF A FRAGMENT OF METAL THAT HAD ENTERED THE INCISION SITE." PATIENT OUTCOME STATUS: RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258181 MANI OPHTHALMIC KNIFE KNIFE, OPHTHALMIC HNN MANI HANOI CO.LTD MSL22SK K259076500

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention