BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA SLIM

    MDR report key: 25303574 · Received May 27, 2026

    Report

    Report Number
    3009809074-2026-00033
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE END USER AND NOT AVAILABLE FOR RETURN, THUS, FURTHER EVALUATION OF THE DEVICE WAS NOT POSSIBLE. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS PERFORMED WHICH IDENTIFIED THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE HISTORY RECORD. THE ASSESSMENT FOUND THAT THE PRODUCT MET RELEASE CRITERIA. ALL DEVICE UNITS PRODUCED FOR THIS LOT HAVE BEEN DISTRIBUTED AND NO OTHER COMPLAINTS OR ADVERSE EVENTS ASSOCIATED WITH THIS LOT HAVE BEEN RECEIVED. NO DEFECTS OR MALFUNCTIONS WERE REPORTED BY THE END USER, WHO ASSOCIATED THE EVENT WITH THE PATIENT'S PRE-EXISTING CONDITION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Description of Event or Problem · 0

    AS REPORTED BY THE TREATING PHYSICIAN, ON (B)(6) 2026, A FEMALE IN HER EARLY 50S WITH STEVENS-JOHNSON SYNDROME-ASSOCIATED INFLAMMATORY DRY EYE WITH MILD PUNCTATE EPITHELIAL EROSIONS (1-2+) DEVELOPED OCULAR REDNESS FOLLOWING USE OF PROKERA SLIM (PKS). AT SCHEDULED DEVICE REMOVAL, CLINICAL EXAM ALSO SHOWED INCREASED CORNEAL STAINING (3+ PUNCTATE EPITHELIAL EROSIONS) WITH SLIGHTLY REDUCED VISUAL ACUITY (20/20 -2). THE PKS WAS REMOVED AND NO DEVICE MALFUNCTION OR PRODUCT DEFECT WAS REPORTED. THE PATIENT WAS TREATED WITH ERYTHROMYCIN ANTIBIOTIC OINTMENT AND PRESERVATIVE-FREE ARTIFICIAL TEARS. AT FOLLOW-UP (ON (B)(6) 2026), FINDINGS HAD RESOLVED AND VISION RETURNED TO BASELINE. THE PHYSICIAN ATTRIBUTED THE EVENT TO UNDERLYING DISEASE RATHER THAN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236890 PROKERA SLIM OPHTHALMIC CONFORMER NQB BIOTISSUE HOLDINGS INC. PKS SM20254397

    Patients

    Seq Age Sex Outcome Treatment
    1