BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO 0,85 ML

    MDR report key: 23410459 · Received October 28, 2025

    Report

    Report Number
    3012236936-2025-000261
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    February 11, 2026
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    05050474761346
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 TO SUSPECT DEVICE AS HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE TO SUSPECT DEVICE AS 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 THIS 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 13-NOV-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: AN OPENED HEALON WAS RECEIVED WITH ORIGINAL PACKAGING CONFIRMING THE LOT NUMBER. A PLASTIC CONTAINER CONTAINING THE ISOLATED FOREIGN MATERIAL WAS INCLUDED. THE COMPLAINT SAMPLE CONSISTED OF AN OPENED PRODUCT BOX, THE DIRECTIONS FOR USE (DFU), AND AN ACTIVATED SYRINGE WITH THE PLUNGER ROD ATTACHED CONTAINING APPROXIMATELY 0.4 ML OF EXPELLABLE HEALON SOLUTION. FOURIER TRANSFORM INFRARED (FTIR) MICRO SPECTROSCOPIC ANALYSIS WAS CONDUCTED. THE ANALYSIS SHOWED NO MATCH TO ANY COMPOUNDS/PACKAGING MATERIAL/COMPONENT MATERIAL KNOWN TO BE USED AT THE PRODUCTION SITE. HOWEVER, BASED UPON THE VISUAL & STEREOMICROSCOPIC OBSERVATIONS AND THE CUSTOMER'S NARRATIVE, THE CUSTOMER'S OBSERVATION AND THE DEVICE PROBLEM CODE "FOREIGN MATERIAL LOOSE" IS CONFIRMED. NO PROBABLE CAUSE FOR THE SOURCE OF THE MATERIAL FIND HAS BEEN FOUND. THE IDENTITY OF THE MATERIAL WAS NOT DETERMINED BASED UPON THE FTIR ANALYSIS AS THE SAMPLE SPECTRUM DID NOT MATCH THAT OF ANY PRODUCT COMPONENT MATERIAL NOR PACKAGING MATERIAL, GOWNING OR CLEANING ARTICLES USED IN HEALONPRO PRODUCTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BLACK FIBER WAS FOUND IN THE HEALON PRO PRODUCT. THROUGH FOLLOW UP, WE LEARNED THAT THE FOREIGN MATERIAL WAS SEEN WHEN IT WAS INTRODUCED INTO THE EYE AND REMOVED BY THE SURGEON. THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51344 HEALON PRO 0,85 ML AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UA31979 05050474761346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown