BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 9892117 · Received March 27, 2020

    Report

    Report Number
    3004750704-2020-00023
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 25, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    UDI-DI
    05050474609631
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED; GIVE DATE: HEALON PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: HEALON PRO IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. (B)(6). DEVICE EVALUATION: NO SAMPLE WAS RETURNED FOR INVESTIGATION AND THEREFORE PRODUCT EVALUATION CANNOT BE PERFORMED. A PRODUCT DEFICIENCY IS NOT CONFIRMED. 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 THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AFTER CORRECT SET-UP OF THE UNIT USING HEALON PRO AS PER DIRECTION FOR USE. DOCTOR DISCOVERED A PARTICLE LATER AND REMOVED IT WITHOUT EXPANDING WOUND OR ANYTHING. AS PER THE SURGEON IT IS UNCLEAR IF THE PARTICLE CAME FROM THE HEALON PRO OR THE IOL. NO FURTHER INFORMATION PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT HEALON PRO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SUSPECT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354139 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TH85ML 05050474609631

    Patients

    Seq Age Sex Outcome Treatment
    1 PCB00, SERIAL NUMBER (B)(6)