BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 24477115 · Received February 27, 2026

    Report

    Report Number
    3009809074-2026-00004
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 27, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT WAS INITIALLY REPORTED BY THE TREATING PHYSICIAN TO A BIOTISSUE MEDICAL SCIENCE LIAISON (MSL) ON (B)((6) 2026. PROKERA SLIM DEVICE WAS PLACED ONTO PATIENT'S RIGHT EYE ON (B)(6) 2026 FOR TREATMENT OF NEUROTROPHIC KERATITIS (NK) AND RECALCITRANT DRY EYE DISEASE. THE PATIENT'S EYE WAS FULLY TAPED CLOSED WITH SURGICAL TAPE AFTER PLACEMENT. AROUND 10:30AM ON (B)(6) 2026, THE PATIENT EXPERIENCED SUDDEN PAIN WHILE WORKING ON THE COMPUTER. THE PATIENT RETURNED TO CLINIC AT WHICH TIME THE PROKERA WAS REMOVED. VISUAL ACUITY WAS OBSERVED TO BE REDUCED TO 20/40. UPON CLINICAL EXAM, A LARGE CENTRAL CORNEAL ABRASION WAS NOTED. THE PATIENT WAS THEN REFERRED TO A CORNEAL SPECIALIST WHO STARTED THE PATIENT ON AN ANTIBIOTIC DROP (MOXIFLOXACIN 4X DAILY) AND PLACED A BANDAGE CONTACT LENS ONTO THE EYE. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2026 AT WHICH TIME THE PATIENT'S PAIN HAD RESOLVED. VISION WAS STILL NOTED TO BE 20/40. CLINICAL EXAM NOTED THE ABRASION HAD RESOLVED. THE PATIENT HAD MILD SUPERFICIAL PUNCTATE KERATITIS (SPK) AND SOME MILD STROMAL HAZE. THE ANTIBIOTIC FREQUENCY WAS REDUCED TO 2X DAILY AND THEN TO BE DISCONTINUED (TAPERED OFF). THE PATIENT WAS STARTED ON A 4-DAY STEROID TAPER (LOTEMAX), TO BE DISCONTINUED BY THE FOURTH DAY. NO FURTHER UPDATES WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536398 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS SM20252948

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention