BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 9467373 · Received December 13, 2019

    Report

    Report Number
    3004750704-2019-00107
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 20, 2019
    Report Date
    November 4, 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

    G9: CORRECTION: IN REVIEW, OF MEDWATCH 3004750704-2019-00107 AND PER NEW INFORMATION RECEIVED, THIS EVENT HAS BEEN ASSESSED NOT REPORTABLE DUE THE FACT THAT CUSTOMER DID NOT LONGER BELIEF THAT PARTICLES CAME FROM A JNJ PRODUCT. THERE WILL BE NO MORE INFORMATION PROVIDED FOR MFG REPORTING NO. 3004750704-2019-00107. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    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. (B)(6). IF IMPLANTED; GIVE DATE: VISCOELASTIC PRODUCT IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: VISCOELASTIC PRODUCT IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CATARACT SURGERY, AFTER A PERFECT DFU PREPARATION, THE DOCTOR OBSERVED A BLACK STRING CAME AROUND AFTER IMPLANTATION. IT HAS BEEN GONE AWAY BY IA. NO PATIENT INJURY REPORTED. SURGEON WAS NOT SURE IF PARTICLE WAS RELATED TO THE INTRAOCULAR LENS, MODEL PCB00 IMPLANTED OR THE VISCOELASTIC (OVD) MODEL HEALON PRO USED DURING PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. THIS REPORT IS RELATED TO THE PRODUCT, VISCOELASTIC HEALON PRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261147 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. 10270012 UE31547 05050474609631

    Patients

    Seq Age Sex Outcome Treatment
    1