BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24607520 · Received March 16, 2026

    Report

    Report Number
    3009809074-2026-00012
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    July 31, 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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 18FEB2026 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.

    Description of Event or Problem · 0

    ON THE MORNING OF (B)(6) 2025 (10AM) DR. CAUGHELL PLACED A PROKERA SLIM ONTO THE EYE FOR TREATMENT OF SEVERE DRY EYE AND SUPERFICIAL PUNCTATE KERATITIS (SPK, 3+ GRADE) SECONDARY TO SJOGREN'S SYNDROME. THE EYE WAS PARTIALLY TAPED AND THE PATIENT'S USUAL DRY EYE MEDICATIONS (MEIBO, RESTASIS AND ARTIFICIAL TEARS) WERE PAUSED DURING PROKERA WEAR AS THE EYE WAS PARTIALLY TAPED. THE PATIENT WAS REPORTED TO BE OK UNTIL AROUND 4PM THAT AFTERNOON, WHEN SHE HAD SUDDEN PAIN. SHE WAS SEEN IN THE OFFICE WHERE THE DOCTOR REMOVED THE PROKERA AND THEN OBSERVED A 2MM CIRCULAR CENTRAL CORNEAL ABRASION. MILD BLURRED VISION (20/400) WAS ALSO NOTED. THE PATIENT DENIES RUBBING THE EYE. THE PROKERA DEVICE WAS REMOVED WITH FORCEPS AND A BANDAGE CONTACT LENS (BCL) WAS PLACED ONTO THE EYE. THE PATIENT WAS PRESCRIBED ANTIBIOTIC DROPS (POLYTRIM) ALTHOUGH THERE WAS NO INDICATION OF INFECTION. AS OF (B)(6) 2025 THE PATIENT WAS REPORTED TO HAVE FULLY HEALED AND VISUAL ACUITY WAS BACK TO BASELINE (20/40). THE TEAR FILM WAS REPORTED TO HAVE BEEN UNSTABLE AND WAS UNCHANGED AFTER ABRASION HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664503 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention