BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON5 PRO OVD

    MDR report key: 12725094 · Received October 30, 2021

    Report

    Report Number
    2020664-2021-07964
    Event Type
    Injury
    Date Received
    October 30, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 29, 2021
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701632
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION UNKNOWN NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE HEALON IS NOT AN IMPLANTED PRODUCT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE HEALON IS NOT AN IMPLANTED PRODUCT. CONCOMITANT MEDICAL PRODUCTS: SIGNATURE PRO MACHINES AND WHITESTAR HANDPIECES. TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. FOR THIS LOT, ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. A SEARCH FOR RELATED COMPLAINTS FOR THE LOT INVOLVED FROM THE LAST 12 MONTHS WAS CONDUCTED AND NO RELATED COMPLAINT(S) WERE FOUND. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE WAS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CATARACT SURGERY, AFTER INJECTING HEALON 5, THE SURGEON STARTED USING ULTRASOUND TO MAKE THE GROOVES. THE SURGEON NOTICED A WHITENING OF THE VISCOUS AND SAW THAT THE CORNEA AT THE INCISION WAS WHITENED AND HAD A CARDBOARD APPEARANCE. THE SURGEON RINSED THE VISCOUS AND USED DUOVISC TO CONTINUE THE SURGERY. AT THE END OF THE SURGERY, SHE HAD TO PUT STITCHES TO KEEP THE INCISION SEALED. IMPORTANT CORNEAL BURN ACCORDING TO HER IMPRESSION AT THE TIME. TO BE FOLLOWED IN POST-OP. THE SURGEON LINKED THE INCIDENT TO THE VISCOUS BUT IT MAY BE A PROBLEM WITH THE IRRIGATION/ASPIRATION. WITHOUT FLOW TO COOL THE TIP, IT CAN QUICKLY HEAT UP. THEY OPERATE WITH SIGNATURE PRO (2 MACHINES IN THIS ACCOUNT) AND WHITESTAR HANDPIECES. THE SURGEON OPERATES IN BIMANUAL (IRRIGATION ON ANOTHER INSTRUMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623163 HEALON5 PRO OVD AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB UJ31276 05050474701632

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention