BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24607624 · Received March 16, 2026

    Report

    Report Number
    3009809074-2026-00016
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    October 29, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4). REFERENCE COVER LETTER IN ATTACHMENTS RE: RETROSPECTIVE SUBMISSION OF MEDICAL DEVICE REPORTS (MDRS) FOLLOWING BIOTISSUE HOLDINGS INC. FDA INSPECTION CONCLUDING ON (B)(6) 2026 (FEI (B)(4)) THE ATTACHED MEDICAL DEVICE REPORT, IS BEING SUBMITTED AS PART OF THE ACTIONS TAKEN BY BIOTISSUE HOLDINGS INC. (BTHI) IN RESPONSE TO FDA INVESTIGATOR FEEDBACK AND A 483 OBSERVATION RECEIVED (B)(6) 2026 REGARDING NOT SUBMITTING MDR REPORT WITHIN 30 DAYS OF BEING AWARE OF INFORMATION THAT REASONABLY SUGGESTED THAT A MARKETED DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY. DURING THE INSPECTION, FEEDBACK AND ADDITIONAL INFORMATION WERE PROVIDED REGARDING THE NEED TO INITIATE MDRS FOR ADVERSE EVENT CASES WHERE ANY MEDICAL OR SURGICAL TREATMENT WAS PROVIDED EVEN WHEN THE CAUSAL RELATIONSHIP TO THE DEVICE IS NOT EVIDENT, EVEN WHEN THE ADVERSE EVENT IS SELF-LIMITED, AND EVEN WHEN SUCH EVENTS MAY ARISE FROM UNDERLYING PATIENT CONDITIONS RATHER THAN DEVICE MALFUNCTION OR PERFORMANCE CONCERNS. THE FEEDBACK RECEIVED EXPANDED THE REPORTABILITY CRITERION BTHI WAS FOLLOWING BASED ON 21 CFR 803 REGULATION. AS BTHI IS FULLY COMMITTED TO COMPLIANCE WITH FDA REPORTING REQUIREMENTS, A RETROSPECTIVE REVIEW OF ADVERSE EVENTS SINCE THE LAST INSPECTION ((B)(6) 2024) WAS COMPLETED. IN THIS LOOK BACK, ADVERSE EVENT CASES ALREADY INVESTIGATED AND DETERMINED NOT REPORTABLE WERE REASSESSED PER THE EXPANDED CRITERIA PROVIDED DURING THE INSPECTION THAT REDEFINED AS REPORTABLE CASES WHERE MEDICAL OR SURGICAL TREATMENT WAS PROVIDED, REGARDLESS OF CLINICAL OUTCOME OR RELATIONSHIP TO DEVICE PERFORMANCE. THE REVIEW IDENTIFIED ADVERSE EVENTS INVESTIGATED BETWEEN (B)(6) 2024 AND (B)(6) 2026 THAT, UPON REASSESSMENT, MET THE EXPANDED CRITERIA FOR REPORTABILITY. THIS MDR SUBMISSION DATE FALLS OUTSIDE THE STANDARD 30 DAY REPORTING REQUIREMENT FROM THE AWARENESS DATE OF THE ADVERSE EVENTS AS THEY WERE IDENTIFIED REPORTABLE PER THE EXPANDED SCOPE AND CRITERIA RECEIVED POST-INSPECTION (B)(6) 2026. WE RESPECTFULLY REQUEST THAT FDA ACCEPT THIS RETROSPECTIVE MDR AS PART OF OUR COMMITMENT TO ADDRESS THE OBSERVATION, PERFORM CORRECTIVE ACTION, ENHANCE REGULATORY COMPLIANCE, AND CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE TREATING PHYSICIAN PLACED A PROKERA SLIM (PKS) INTO THE LEFT EYE OF A PATIENT FOR TREATMENT OF DIFFUSE 3+ SUPERFICIAL PUNCTATE KERATITIS (SPK) AND DRY EYE DISEASE (DED). NO FIT ISSUES WERE NOTED AT TIME OF PLACEMENT. PATCH TARSORRHAPHY WAS APPLIED AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE DEVICE WELL OVERNIGHT. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE CLINIC SHOWING SIGNIFICANT BLEEDING IN THE EYE WHERE THE DEVICE HAD BEEN PLACED. ANOTHER PHYSICIAN REMOVED THE DEVICE AND NOTED THAT THE AMNIOTIC MEMBRANE WAS STILL INTACT ON THE RING, BUT THE ENTIRE DEVICE WAS COVERED IN BLOOD, WITH THE EYE NOTED TO BE BLEEDING. IT APPEARED TO BE A CONJUNCTIVAL LACERATION. THE PHYSICIAN CLEANED THE AREA AND APPLIED GAUZE AND TAPE. THE PATIENT WAS INSTRUCTED TO APPLY PRESERVATIVE-FREE ARTIFICIAL TEARS EVERY 30 MINUTES-1 HOUR. THE PATIENT RETURNED FOR FOLLOW UP ON (B)(6) 2025, AT WHICH TIME THE PATIENT'S USUAL PHYSICIAN EVALUATED THE EYE, AND REPORTED IMPROVEMENT WITH "NO SIGNIFICANT INJURY." ONCE IMPROVEMENT AND HEALING WERE NOTED, PROPHYLACTIC ANTIBIOTIC DROPS WERE PRESCRIBED. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE PHYSICIAN NOTED THE LACERATION AND HEMORRHAGE HAD RESOLVED ALTHOUGH THERE WAS A SLIGHT DECREASE IN VISUAL ACUITY COMPARED TO THE PRE-PROKERA PLACEMENT. A STEROID DROP WAS PRESCRIBED AT THIS TIME. BY (B)(6) 2025, THE PATIENT'S VISION HAD RETURNED TO BASELINE AND ALL ISSUES HAD FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669466 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS SM20252694

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention PROPARACAINE (TOPICAL ANESTHETIC).