BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA SLIM

    MDR report key: 25085497 · Received May 5, 2026

    Report

    Report Number
    3009809074-2026-00027
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROKERA DEVICE WAS NOT RETURNED FOR EVALUATION, THUS FURTHER REVIEW OF THE DEVICE CANNOT BE COMPLETED TO ASSESS FOR DEFECTS OR MALFUNCTIONS (ALTHOUGH NEITHER WERE REPORTED). THE PRODUCT LOT NUMBER WAS NOT PROVIDED OR AVAILABLE, THUS FURTHER REVIEW OF THE PRODUCTION RECORDS WAS ALSO UNABLE TO BE PERFORMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 0

    A FEMALE PATIENT WITH SEVERE DRY EYE WAS TREATED WITH MULTIPLE PROKERA SLIM (PKS) DEVICES. ON (B)(6) 2026, SHE REPORTED TO BIOTISSUE CUSTOMER SERVICE THAT SHE EXPERIENCED BURNING AND DISCOMFORT WITH HER MOST RECENT PKS DEVICE, WHICH HAD BEEN INSERTED SEVERAL WEEKS EARLIER (EXACT DATE NOT REPORTED). THE TREATING PHYSICIAN REPORTED NO COMPLICATIONS OR OCULAR ABNORMALITIES ON EXAM BUT HAD APPLIED A BANDAGE CONTACT LENS SOME TIME AFTER DEVICE REMOVAL (NOT SPECIFIED) DUE TO THE DISCOMFORT/BURNING SYMPTOMS. THE PHYSICIAN BELIEVED THE DISCOMFORT MAY HAVE BEEN RELATED TO THE PATIENT'S UNDERLYING DISEASE AND/OR THE PROKERA RING BUT STATED THAT THE TREATMENT HAD GONE VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573073 PROKERA SLIM OPHTHALMIC CONFORMER NQB BIOTISSUE HOLDINGS INC. PKS

    Patients

    Seq Age Sex Outcome Treatment
    1