BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA SLIM

    MDR report key: 25086062 · Received May 5, 2026

    Report

    Report Number
    3009809074-2026-00028
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 1, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROKERA SLIM DEVICE WAS DISCARDED IN THE ER AND WAS THEREFORE NOT RETURNED FOR FURTHER EVALUATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS COMP-(B)(4).

    Description of Event or Problem · 0

    A 38-YEAR-OLD FEMALE WITH DRY EYE AND SUPERFICIAL PUNCTATE KERATITIS UNDERWENT UNCOMPLICATED PLACEMENT OF A PROKERA SLIM DEVICE IN THE RIGHT EYE ON (B)(6) 2026. ON (B)(6) 2026, WHILE REMOVING THE EYE PATCH TO INSTILL DROPS AND CLEAN THE EYE, THE PATIENT REORTED EXPERIENCING A SUDDEN ONSET OF SIGNIFICANT EYELID SWELLING WITH COPIOUS THICK WHITE PURULENT DISCHARGE AND WORSENING DISCOMFORT. SHE PRESENTED TO THE EMERGENCY ROOM THE SAME EVENING, WHERE THE DEVICE WAS REMOVED AND AN OCULAR CULTURE OBTAINED. NO FINDINGS WERE REPORTED FROM THE ER VISIT. THE ER PRESCRIBED MOXIFLOXACIN OPHTHALMIC SOLUTION, WITH INITIATION DELAYED UNTIL (B)(6) 2026 DUE TO PHARMACY CLOSURE. SYMPTOMS WERE REPORTED BY THE TREATING OPTOMETRIST ON (B)(6) 2026 AS IMPROVING AFTER ANTIBIOTIC INITIATION. A CORNEAL SPECIALIST EVALUATED THE PATIENT ON (B)(6) 2026 AND FELT THE PRESENTATION WAS MOST CONSISTENT WITH INFECTION RATHER THAN ALLERGY. NO DEFINITIVE CAUSALITY ASSESSMENT WAS DOCUMENTED BY THE CORNEAL SPECIALIST AND NO TREATMENTS FROM THE CORNEAL SPECIALIST WERE REPORTED. ON (B)(6) 2026, CULTURE RESULTS CAME BACK AND WERE POSITIVE FOR PSEUDOMONAS AERUGINOSA; FINAL RESOLUTION AND VISUAL OUTCOME WERE NOT REPORTED ALTHOUGH THE PATIENT WAS NOTED TO BE IMPROVING. NOTE: DURING THE ER VISIT, PUNCTAL PLUGS WERE MANIPULATED AND BECAME IMPACTED IN THE PUNCTUM, NECESSITATING SUBSEQUENT SURGICAL REMOVAL BY OCULOPLASTICS (PROCEDURE DETAILS NOT REPORTED). A COMPREHENSIVE INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER, INCLUDING REVIEW OF DONOR ELIGIBILITY AND INFECTIOUS DISEASE SCREENING, TISSUE RECOVERY CONDITIONS, PROCESSING RECORDS, ENVIRONMENTAL MONITORING, PRODUCT BIOBURDEN TESTING, AND STORAGE AND DISTRIBUTION HISTORY FOR THE PROKERA SLIM LOT USED. DONOR SCREENING AND SEROLOGIC TESTING WERE NON-REACTIVE AND MET ALL REGULATORY ACCEPTANCE CRITERIA, WITH NO EVIDENCE OF DONOR-DERIVED INFECTION RISK. TISSUE RECOVERY, PROCESSING, AND MANUFACTURING WERE PERFORMED PER PROCEDURES IN CONTROLLED ENVIRONMENTS, WITHOUT DEVIATIONS OR NONCONFORMANCES. PRE-PROCESSING MICROBIOLOGICAL TESTING, ENVIRONMENTAL MONITORING, AND FINAL PRODUCT BIOBURDEN TESTING DEMONSTRATED NO MICROBIAL GROWTH, INCLUDING NO PRESENCE OF PSEUDOMONAS AERUGINOSA. REVIEW OF ADVERSE EVENT DATA IDENTIFIED NO CLUSTERING OR SIMILAR EVENTS ASSOCIATED WITH THIS PRODUCT LOT. OVERALL, NO EVIDENCE WAS FOUND TO SUGGEST CONTAMINATION, MANUFACTURING FAILURE, OR PRODUCT- OR DONOR-RELATED SOURCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498496 PROKERA SLIM OPHTHALMIC CONFORMER NQB BIOTISSUE HOLDINGS INC. PKS SM20254648

    Patients

    Seq Age Sex Outcome Treatment
    1