BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 11092677 · Received December 29, 2020

    Report

    Report Number
    3004750704-2020-00077
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION AND BASED ON LIMITED INFORMATION AVAILABLE, IT CANNOT BE DETERMINED IF THERE IS A PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALON PRO HAD A WHITE PARTICLE THAT CAME OUT OF THE CANNULA TIP. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THERE WAS PATIENT CONTACT. THE WHITE PARTICLE WAS IN THE EYE, HOWEVER, THE SURGEON WAS ABLE TO REMOVE IT FROM THE PATIENT'S OPERATIVE EYE. THERE WAS NO PATIENT INJURY. IT WAS CONFIRMED THE CANNULA WAS NOT BEING REUSED. THE HEALON AND DEBRIS IS NOT AVAILABLE FOR RETURN AS IT HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556563 HEALON PRO OVDS LZP JOHNSON & JOHNSON SURGICAL VISION, INC. TH85ML UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1