BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON DUET

    MDR report key: 21408225 · Received February 19, 2025

    Report

    Report Number
    3012236936-2025-000047
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Report Date
    February 18, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS PRIOR TO (B)(6) 2025. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION E1: FIRST/GIVEN NAME: UNKNOWN, INFORMATION WAS NOT PROVIDED. SECTION H3(NO): THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DOCTOR OBSERVED GRAY MATTER EMERGING ALONGSIDE THE VISCOAT WHEN TESTED NEAR AN LEFT EYE INCISION, WHICH WAS ONLY VISIBLE UNDER A MICROSCOPE. THEY HAD ALREADY PRIMED THE VISCOAT ON THE MAYO STAND AS WELL AND IT WAS NOTED THAT THE GREY MATTER DID NOT GET INTO THE PATIENT'S EYE. IT WAS NOTED THAT THE PRODUCT WAS OBTAINED AS PART OF A HEALON DUET AND THE ACCOUNT THINKS THE GRAY MATTER CAME FROM THE HEALON ENDOCOAT PRODUCT. IT WAS CONFIRMED THAT THE GRAY MATTER FULLY REMOVED AND THE PROCEDURE SUCCESSFULLY COMPLETED. NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT'S OUTCOME WAS REPORTED TO BE NORMAL, FINISHED SURGERY AS EXPECTED. TROUGH FOLLOW UPS, IT WAS CLARIFIED THAT THE GRAY MATTER WAS NOTICED WHEN THE SURGEON PRIMED THE SYRINGE NEXT TO THE INCISION ON THE EYE. THE MATTER TOUCHED THE EYEBALL BUT DID NOT GO INSIDE THE INCISION AREA. THEY USED A WECK TO REMOVE MOST OF THE MATTER AND THEN FLUSHED THE EYE WITH BALANCED SALT SOLUTION (BSS). THEY OPENED A NEW HEALON AND CONTINUED THE SURGERY. THE DOCTOR MENTIONED HE HAS HAD THIS ISSUE HAPPEN ONCE BEFORE AND LOOKED THE SAME. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE EARLIER INCIDENT WHICH THE DOCTOR EXPERIENCED. A SEPARATE REPORT WAS SUBMITTED FOR SECOND INCIDENT WHICH OCCURRED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58267 HEALON DUET AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB VT585U UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown