BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 12601360 · Received October 8, 2021

    Report

    Report Number
    2020664-2021-07703
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Report Date
    October 8, 2021
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED. MODEL #: UNKNOWN/NOT PROVIDED. LOT#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IMPLANT DATE: N/A. THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: N/A. THE HEALON PRO IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE HEALON PRO UNITS WERE NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE HEALON PRO UNITS COULD NOT BE REVIEWED SINCE NO LOT 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 CANNULA LUER LOCK WAS LOOSE AND COULD NOT BE AFFIXED PROPERLY. THE CANNULA GOT LOOSE FROM THE SYRINGE DURING INJECTION OF THE VISCOELASTIC MATERIAL. ACCOUNT PROVIDED THAT THIS OCCURRENCE WAS OBSERVED IN 50% OF THE CASES. NO PATIENT ISSUES WERE REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497086 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB

    Patients

    Seq Age Sex Outcome Treatment
    1