BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON ENDOCOAT

    MDR report key: 12991179 · Received December 13, 2021

    Report

    Report Number
    3012236936-2021-00218
    Event Type
    Injury
    Date Received
    December 13, 2021
    Report Date
    December 13, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474547063
    PMA / PMN Number
    P110007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE IMPLANTED: NOT APPLICABLE, AS HEALON IS NOT AN IMPLANTABLE DEVICE. DATE EXPLANTED: NOT APPLICABLE, AS HEALON IS NOT AN IMPLANTABLE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE, A VISUAL ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/ LOT HISTORY RECORD AND HISTORICAL DATA ANALYSIS FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS SEEING 2200 (20/200), HAD LOW VISIBILITY, AND INCREASED OCULAR PRESSURE IN THE OCULAR SINISTER (LEFT EYE). ACCOUNT STATED SHE FEELS THIS IS RELATED TO THE HEALON. SHE SAID HEALON OPERATED WELL, BUT ANOTHER PATIENT HAD THE SAME ISSUE AFTER IT WAS USED; THE DOCTOR DOES NOT WANT TO USE IT. NO SURGICAL INTERVENTION IS SCHEDULED, AS THEY FEEL THAT THE ISSUE WITH THE OCULAR PRESSURE WILL RESOLVE ITSELF WHEN THE BODY ABSORBS IT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD CORNEA SWELLING AND INTEROCULAR PRESSURE. ALL NEGATIVE SYMPTOMS REPORTED, WENT AWAY. THE FOLLOW-UP VISIT SHOWED NO RESIDUAL SYMPTOMS AND THE PATIENT WAS SEEING GREAT RESULTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES PATIENT #2, A SEPARATE REPORT WILL CAPTURE PATIENT #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884548 HEALON ENDOCOAT AID, SURGICAL, VISCOELASTIC LZP JOHNSON & JOHNSON SURGICAL VISION, INC. VT585U 029169 05050474547063

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other