BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON PRO

    MDR report key: 10365242 · Received August 4, 2020

    Report

    Report Number
    3004750704-2020-00040
    Event Type
    Injury
    Date Received
    August 4, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND (B)(4) .

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: EXACT DATE UNKNOWN, AROUND 20 DAYS PRIOR TO THE (B)(6) 2020. CATALOG #, SERIAL/LOT#, UDI# AND EXPIRATION DATE: UNKNOWN/NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. REPORTER PHONE: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE HEALON UNIT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE PRODUCT COULD NOT BE REVIEWED SINCE NO LOT/SERIAL DETAILS COULD BE OBTAINED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON NOTICED AN INCREASE OF POST-OPERATIVE INTRAOCULAR PRESSURE (IOP) AND A SMALL HEMORRHAGIC BLEEDING REQUIRING MEDICATION TO RELEASE THE PRESSURE FROM THE EYE. THE SURGEON DID PROCEDURES AS USUAL AND COULD NOT CONFIRM WHAT CAUSED THE INCIDENT, BUT HE WAS TRYING NOW TO AVOID FUTURE PROBLEMS. THROUGH FOLLOW-UP WE LEARNT THAT THE EXACT INCIDENT DATE IS NOT KNOWN BUT IS THOUGHT TO BE ABOUT 2 WEEKS PRIOR TO THE REPORT BEING MADE TO JOHNSON & JOHNSON VISION. THE CUSTOMER IS NOT SURE OUR PRODUCT WAS THE CAUSE. THE EXACT LOT NUMBER IS ALSO UNCLEAR AND CANNOT BE PROVIDED. THE PATIENT WAS TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827757 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TH85ML

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention