BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 10318368 · Received July 24, 2020

    Report

    Report Number
    3004750704-2020-00034
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 26, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    NURSE

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A. HEALON PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A. HEALON PRO IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. INITIAL REPORTER PHONE: (B)(6). DEVICE EVALUATION: THE HEALON PRO 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 INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME FIBERS WERE OBSERVED IN THE PATIENT EYE WHILE INSERTING THE HEALON PRO. THE SURGEON TRIED TO REMOVE THE FIBER WITH TWEEZERS BUT IT DID NOT SUCCEED. SURGEON THEN FLUSHED THE EYE WITH BALANCE SALINE SOLUTION (BSS) TO REMOVE THE FIBER. HOWEVER, IT IS UNKNOWN IF THE FIBER WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782539 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TH85ML UH31072

    Patients

    Seq Age Sex Outcome Treatment
    1