BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 22561855 · Received July 21, 2025

    Report

    Report Number
    3012236936-2025-000186
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Report Date
    February 4, 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

    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 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 HEALON 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 26-AUG-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE HEALON PRO WAS RECEIVED WITHIN ITS ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER. COMPLAINT SAMPLE CONSISTED OF AN ACTIVATED SYRINGE WITH NO EXPELLABLE HEALON SOLUTION IN IT. A BLACK THREAD WAS ALSO RECEIVED. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) MICRO SPECTROSCOPY ANALYSIS OF THE BLACK THREAD WAS CONDUCTED, AND THE ANALYSIS OF THE ACQUIRED SPECTRUM SHOWED NO MATCH TO ANY COMPOUNDS/PACKAGING MATERIAL/COMPONENT MATERIAL KNOWN TO BE USED AT THE MANUFACTURING SITE. BASED UPON THE VISUAL & STEREOMICROSCOPIC OBSERVATIONS AND THE CUSTOMER'S NARRATIVE, THE CUSTOMER'S OBSERVATION AND THE DEVICE PROBLEM "FOREIGN MATERIAL LOOSE" IS CONFIRMED. THE IDENTITY OF THE MATERIAL WAS NOT DETERMINED, AND NO PROBABLE CAUSE FOR THE SOURCE OF THE MATERIAL FIND HAS BEEN FOUND. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. 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

    CORRECTION UPON FURTHER REVIEW IT WAS NOTICED THAT SECTION D4: DEVICE CATALOG NUMBER WAS INADVERTENTLY REPORTED INCORRECT. THE CORRECT VALUES ARE AS FOLLOWS: SECTION D4 DEVICE CATALOG NUMBER: 10311012 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL BLACK THREAD WAS FOUND IN THE HEALON PRODUCT. THE DOCTOR REMOVED THE THREAD FROM THE PATIENT'S EYE DURING THE IMPLANTATION PROCESS. THE PATIENT WAS NOT PERMANENTLY OR TEMPORARILY IMPAIRED AND DID NOT SEEK FURTHER MEDICAL ATTENTION. ACCOUNT INDICATED THAT THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398123 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UP31873 05050474761360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown