BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON PRO

    MDR report key: 10766963 · Received October 30, 2020

    Report

    Report Number
    3004750704-2020-00051
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT IN THE INITIAL REPORT THE PRODUCT REFERENCED SECTION H10 TO ADDRESS SECTION D6 AND D7 WAS PROVIDED AS HEALON ENDOCOAT, HOWEVER THE COMMENTS SHOULD HAVE REFERENCED HEALON PRO. THEREFORE, THE APPROPRIATE COMMENTS ENTERED IN H10 TO ADDRESS SECTION D6 & D7 SHOULD READ AS: SECTION D6: IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. SECTION D7: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON ENDOCOAT IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON ENDOCOAT IS NOT AN IMPLANTABLE DEVICE. OTHER: THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE ACCOUNT; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOXIC ANTERIOR SEGMENT SYNDROME (TASS) CASE OCCURRED IN A PATIENT. HEALON PRO, LOT# UH31179 AND HEALON ENDOCOAT, LOT# 028612, WERE USED. IT WAS STATED THAT THIS CASE WAS THE LAST CASE OF THE DAY. THE PATIENT IS DOING WELL AFTER BEING STARTED ON STEROID TREATMENTS. UPON FURTHER FOLLOW-UP, THE CONTACT PERSON DOES NOT HAVE THE PRODUCT USED DURING THIS CASE TO SEND BACK FOR EVALUATION. THE PATIENT WAS TREATED WITH LOTEMAX (STEROID) EVERY 1 HOUR AND BESIVANCE (ANTIBIOTIC) EVERY 2 HRS. AT LAST APPOINTMENT, VISION IS IMPROVING. IT WAS LEARNED THAT BOTH THE HEALON PRO AND THE HEALON ENDOCOAT ARE KEPT IN THE REFRIGERATOR UNTIL THE MORNING OF THE CASE. THE TEMPERATURE LOG THAT DAY OF THE CASE DID NOT SHOW ANY CHANGE IN TEMPERATURE THAT WOULD BE OUT OF THE NORMAL RANGE. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT HEALON PRO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SUSPECT HEALON ENDOCOAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225732 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON PRO UH31179

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention