BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON ENDOCOAT

    MDR report key: 11042220 · Received December 18, 2020

    Report

    Report Number
    3004750704-2020-00074
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    August 7, 2020
    Report Date
    January 21, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P110007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER, INDICATED THE PATIENT WAS A FEMALE AND THAT THE POST-OP DROPS GIVEN TO THE PATIENT WERE OFLOXACIN, LOTEMAX AND PROLENZA. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION A3: SEX/GENDER: FEMALE; SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION; SECTION D11: CONCOMITANT MEDICAL PRODUCTS: PHACO MACHINE, SN UNKNOWN, PHACO DISPOSABLE TUBING, LOT UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SEX/GENDER: UNKNOWN/ NOT PROVIDED. 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. CONCOMITANT MEDICAL PRODUCTS: INTRAOCULAR LENS, MODEL ZCB00, BALANCED SALT SOLUTION (BSS) IRRIGATION SOLUTION, PROL YSTICA, QUICK RINSE. PHONE NUMBER: UNKNOWN/ NOT PROVIDED. 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. 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) OCCURRED IN THE LEFT EYE OF A PATIENT. BESIVANCE OPHTHALMIC EYE DROPS 3X DAILY FOR 1 WEEK (NORMAL POST CATARACT ORDER) WAS PRESCRIBED TO THE PATIENT. IT WAS INDICATED THAT THE WAS A SEVERE INFLAMMATION; HOWEVER, THE PATIENT HAS RECOVERED. THE LENS REMAINS IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT IS FOR THE HEALON ENDOCOAT DEVICE. A SEPARATE EMDR IS BEING SUBMITTED FOR THE INTRAOCULAR LENS, MODEL ZCB00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500701 HEALON ENDOCOAT OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON ENDOCOAT 028551

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R