BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24617461 · Received March 17, 2026

    Report

    Report Number
    3009809074-2026-00008
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 10, 2025
    Report Date
    March 12, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 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 02/18/2026. 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 REGULATIONS. AS BTHI IS FULLY COMMITTED TO COMPLIANCE WITH FDA REPORTING REQUIREMENTS, A RETROSPECTIVE REVIEW OF ADVERSE EVENTS SINCE THE LAST INSPECTION (MAR 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 WERE MEDICAL OR SURGICAL TREATMENT WAS PROVIDED, REGARDLESS OF CLINICAL OUTCOME OR RELATIONSHIP TO DEVICE PERFORMANCE. THE REVIEW IDENTIFIED ADVERSE EVENTS INVESTIGATED BETWEEN MARCH 2024 AND FEBRUARY 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 02/18/2026. 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

    A PATIENT WITH NEUROTROPHIC KERATITIS (NK), SUPERFICIAL PUNCTATE KERATITIS (SPK 1+ TO 2+) AND MILD REDUCED VISION (20/30), HAD A PROKERA SLIM INSERTED ON (B)(6) 2025 TO HELP WITH THE NK, SPK AND HOPEFULLY GET CLEARER VISION. A TOPICAL ANESTHETIC WAS USED AT THE TIME OF DEVICE INSERTION. THE PATIENT RETURNED TO THE OFFICE APPROXIMATELY 1 HOUR AFTER PLACEMENT WITH SIGNIFICANT EYE WATERING AND COMPLAINED OF BURNING AND PAIN ON THE OUTSIDE CORNER OF HER LEFT EYE. THE PHYSICIAN REMOVED THE PROKERA AND STATED THAT THE CORNEA WAS HAZY, THE PRE-EXISTING SPK HAD WORSENED TO 4+ AND VISION HAD DECLINED TO 20/150. THE PATIENT WAS PRESCRIBED MAXITROL (STEROID/ANTIBIOTIC COMBO) AND ANTIBIOTICS AT TIME OF PROKERA REMOVAL. AT THE NEXT FOLLOW-UP (NEXT DAY), CORNEAL HAZE HAD IMPROVED, BUT VISION REMAINED DECREASED. LOTEMAX STEROID OINTMENT WAS THEN PRESCRIBED. STEROID FREQUENCY WAS INCREASED; PATIENT WAS NOTED TO BE IMPROVING AND THE SPK RESOLVED; THE PHYSICIAN IS NOW TAPERING OFF THE STEROID. AS OF (B)(6) 2025, PATIENT'S VISION HAS RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678664 PROKERA PKS NQB BIOTISSUE HOLDINGS INC. PKS TGBA24G009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention