BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON 5 PRO

    MDR report key: 14438405 · Received May 19, 2022

    Report

    Report Number
    3012236936-2022-01320
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 27, 2022
    Report Date
    December 3, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474701663
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS HEALON5 PRO IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS HEALON5 PRO IS NOT AN IMPLANTABLE DEVICE. INITIAL REPORTER PHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 18 JUL 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. RETURNED COMPLAINT SAMPLE CONSISTED OF AN ACTIVATED SYRINGE WITH NO EXPELLABLE HEALON SOLUTION LEFT. THE PLUNGER ROD WAS NOT RETURNED. THE CANNULA WAS ATTACHED AT THE LUER MOUNT ON THE HOLDER. A SEPARATE CUSTOMER CANNULA WITH CANNULA GUARD CONTAINING FOREIGN MATERIAL AT THE TIP OF THE NEEDLE WAS RECEIVED. FURTHER ANALYSIS REVEALED THAT THE MATERIAL WAS SPECTRALLY CLOSE TO A MATERIAL IDENTIFIED AS "BUPIVACAINE", A LOCAL ANESTHETIC COMPOUND USED DURING SURGERIES. THE CLINIC HAS VERIFIED THE USE OF TETRACAINE AND INTRACAMERAL XYLOCAINE 1%, NON-PRESERVED, DURING THE SURGERY. BUPIVACAINE IS STRUCTURALLY SIMILAR TO XYLOCAINE/LIDOCAINE. THE RETURNED SAMPLE MATERIAL IS NOT CHARACTERIZED AS A PARTICLE OF PLASTIC. THE REPORTED ISSUE IS NOT CONFIRMED. BASED ON THE SAMPLE EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT UNIT HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INJECTION OF THE OPHTHALMIC VISCOELASTIC MATERIAL (HEALON5 PRO) A SMALL PARTICLE OF PLASTIC WAS OBSERVE IN THE PATIENT'S OPERATIVE EYE. NO PATIENT INJURY WAS REPORTED. THERE WAS NO MEDICAL INTERVENTION OR SURGICAL INTERVENTION REQUIRED. THE PATIENT HAS REPORTEDLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392486 HEALON 5 PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TV60ML UJ31437 05050474701663

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female