BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 23334028 · Received October 19, 2025

    Report

    Report Number
    3012236936-2025-000257
    Event Type
    Malfunction
    Date Received
    October 19, 2025
    Report Date
    April 2, 2026
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474761360
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES, SECTION D9 - DATE RETURNED TO MANUFACTURER: 18-DEC-2025, SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: TWO COMPLAINT SAMPLES CONSISTED OF ACTIVATED SYRINGES WITH APPROXIMATELY 0.1 ML OF REMAINING EXPELLABLE HEALON PRO SOLUTION AND CANNULAS. THE ASSEMBLED SYRINGE WAS PLACED IN THE PRODUCT BOX TOGETHER WITH THE DIRECTIONS FOR USE (DFU). THE MATERIAL FINDS RELATED TO THIS COMPLAINT WERE PLACED ON THE TIP OF A WHITE ARROW AND ON THE SURFACE OF A WHITE SPONGE LIKE SUBSTANCE. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) MICROSCOPIC ANALYSIS WAS PERFORMED ON THE SMALL BLACK THREADS SENT BY THE CUSTOMER. NEITHER SPECTRUM MATCHED ANY HEALON PRO PRODUCT MATERIALS, PACKAGING, GOWNS, OR CLEANING ITEMS. BASED ON THE CUSTOMER¿S NARRATIVE AND RECOVERY OF THE MATERIAL FINDS FROM THE HEALON SOLUTION, THE COMPLAINT IS CONFIRMED. HOWEVER, AS THERE WAS NO DIRECT EVIDENCE THAT THE SOURCE OF THE FIBERS ORIGINATED FROM THE COMPLAINT SAMPLES, A PRODUCT NON CONFORMITY CANNOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3 - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE HEALON PRO, A SMALL BLACK THREAD WAS OBSERVED IN THE PRODUCT. THE BLACK THREAD WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S EYE. THE ISSUE WAS FIRST IDENTIFIED DURING THE IMPLANTATION/APPLICATION PROCESS. THE PATIENT FULLY RECOVERED AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THROUGH FOLLOW UP, WE LEARNED THAT THE CUSTOMER IS UNSURE OF THE EVENT DATE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84146 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UA31957 05050474761360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown