BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROKERA

    MDR report key: 23328242 · Received October 17, 2025

    Report

    Report Number
    3009809074-2025-00005
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INITIAL REPORT WAS SUBMITTED ON 09/17/2025 TO COMPLY WITH REPORTING REQUIREMENTS AS THE INVESTIGATION WAS ON-GOING AND THERE WAS NOT ENOUGH INFORMATION TO MAKE A REPORTABILITY DETERMINATION (DEVICE WAS RETURNED ON 08/27/2025 AND INITIAL ASSESSMENT OF THE DEVICE BY THE PRODUCT DEVELOPMENT TEAM WAS COMPLETED ON 09/17/2025). THE REPORT SUBMITTED ON 09/17 PASSED ACK1 AND ACK2 BUT FAILED ACK3. A FOLLOW-UP (FINAL) REPORT WAS ATTEMPTED TO BE SUBMITTED ON 10/10/2025 WHICH ALSO FAILED ACK3. A MESSAGE WAS SENT TO [email protected] ON 10/14/2025 TO REQUEST GUIDANCE. IT WAS DETERMINED TO THEN COMBINE THE INFORMATION FROM THE INITIAL REPORT AND FINAL REPORT AND ATTEMPT THE SUBMISSION AGAIN (THIS REPORT).

    Description of Event or Problem · 0

    INITIAL INVESTIGATION: ON (B)(6) 2025, BIOTISSUE DISTRIBUTOR ORIENT EUROPHARMA (OEP) RECEIVED A COMPLAINT FROM A CUSTOMER FACILITY, (B)(6) HOSPITAL. THEY REPORTED THAT FOLLOWING SURGERY ON (B)(6) 2025, THE PATIENT EXPERIENCED SEVERE EYE PAIN WHEN THE PROKERA (PK-16) DEVICE WAS PLACED. ROTATING THE DEVICE PROVIDED TEMPORARY RELIEF, BUT THE PATIENT REPORTED SEVERE PAIN AGAIN DURING A FOLLOW-UP VISIT THAT AFTERNOON. AT THE ON (B)(6) 2025 AFTERNOON FOLLOW-UP APPOINTMENT, THE PROKERA DEVICE WAS REMOVED AND REPLACED WITH A VERSION OF PROKERA WITH A LOWER PROFILE, PROKERA SLIM (PKS). ON (B)(6) 2025, THE PATIENT WAS SEEN FOR FOLLOW-UP WHERE THE DEVICE WAS REMOVED AS SCHEDULED AND THE PATIENT WAS FINE (GOOD RECOVERY). NO HARM ASIDE FROM DISCOMFORT OCCURRED AND NO DEFECT ON THE DEVICE WAS REPORTED BY THE USER FACILITY. THE PK-16 DEVICE WAS RETURNED TO BIOTISSUE FOR FURTHER INSPECTION, WHICH IDENTIFIED THAT THE DEVICE WAS APPROPRIATELY ASSEMBLED WITH NO VISUALLY NOTICEABLE DEFECTS IN ITS ASSEMBLED STATE. HOWEVER, UPON DEVICE DISASSEMBLY AND INSPECTION UNDER MAGNIFICATION, GATE REMNANTS AND FLASH WERE OBSERVED ON BOTH THE SKIRT AND RING DEVICE COMPONENT PARTS. THE GATE REMNANT, ONCE THE DEVICE WAS DISASSEMBLED, WAS ABLE TO BE FELT WITH FINGERS. IT WAS CONFIRMED THAT ONE COMPONENT HAS A REMNANT PRESENT IN AN AREA WHICH POTENTIALLY COULD HAVE CONTACT WITH THE OCULAR SURFACE AND HAS POTENTIAL TO CONTRIBUTE TO THE DISCOMFORT THE PATIENT EXPERIENCED. FOLLOW UP INFORMATION: THE INITIAL REPORT (INITIAL INVESTIGATION ABOVE) WAS SUBMITTED ON 09/17/2025 TO COMPLY WITH REPORTING REQUIREMENTS. THE INVESTIGATION WAS STILL IN PROGRESS, SO A PRELIMINARY REPORT WAS SUBMITTED AT THAT TIME. THE SUBMISSION PASSED ACK1 AND ACK2 BUT FAILED ACK3. REFER TO SECTION H11 ADDITIONAL MANUFACTURER NARRATIVE FOR DETAILS. UPON RECEIPT OF THE COMPLAINT SAMPLE, IT WAS EVALUATED TOGETHER WITH THE RING AND SKIRT DEVICE COMPONENTS. DIMENSIONAL ANALYSIS OF THE DEVICE COMPONENTS WAS PERFORMED PER CURRENT MATERIAL SPECIFICATIONS AND COMPONENTS DIMENSIONS WERE MEASURED BY THE CURRENT APPROVED SUPPLIER FOR DIMENSIONAL ANALYSIS TO DETERMINE IF THERE WERE ANY DEFECTS DETECTED IN THE PARTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE RESULTS OF THE COMPLAINT SAMPLE EVALUATION AND THE COMPONENTS EVALUATION CONFIRMED THAT BOTH THE RING AND SKIRT COMPONENTS COMPLIED WITH THE DEFINED CRITICAL DIMENSIONS AND SPECIFICATIONS. ADDITIONALLY, THE GATE REMNANTS OBSERVED WERE CONFIRMED TO BE AS EXPECTED PER THE PART MANUFACTURING AND THAT THEY WERE LOCATED IN AREAS THAT WOULD NOT COME IN CONTACT WITH THE OCULAR SURFACE UPON USE AND THAT THEY WOULD NOT CONTRIBUTE TO ANY TEAR OR HOLES IN THE TISSUE OR THE AM CLIPPED ON TO THE RING AND SKIRT. BASED ON THESE EVALUATIONS AND TEST RESULTS, THE PRODUCT IS CONFIRMED TO MEET ACCEPTANCE CRITERIA AND IS DEEMED CONFORMING TO DESIGN REQUIREMENTS. NO DEVIATION WAS IDENTIFIED TO CONTRIBUTE TO THE REPORTED EVENT. THERE ARE NO OTHER COMPLAINTS RECEIVED FOR THIS LOT. UPON CONCLUSION OF THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT AND NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828022 PROKERA PROKERA CLASSIC NQB BIOTISSUE HOLDINGS INC. PK16 BTDS2024-13089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other