BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROKERA

    MDR report key: 22754652 · Received August 8, 2025

    Report

    Report Number
    3009809074-2025-00004
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BIOTISSUE HOLDINGS INC.
    Product Code
    NQB
    PMA / PMN Number
    K032104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FDA VIA A CONSUMER MEDWATCH REPORT (MW5168899). THE PATIENT THEN REPORTED THIS EVENT TO BIOTISSUE, WHO LATER WAS ALSO CONTACTED BY THE FDA WITH A COPY OF THE MEDWATCH REPORT ((B)(6) 2025). TO SHOW THAT BIOTISSUE HAS FULLY ASSESSED THIS ADVERSE EVENT, BIOTISSUE WILL BE SUBMITTING THIS MANUFACTURER MEDWATCH REPORT (FORM FDA- 3500) TO THE FDA ALTHOUGH THIS EVENT DOES NOT MEET THE REQUIREMENTS FOR MANDATORY MEDICAL DEVICE ADVERSE EVENT REPORTING. ON SECTION H. 1. TYPE OF REPORTABLE EVENT - ESUBMITTER REQUIRED A SELECTION FOR THIS FIELD ALTHOUGH NONE OF THE TERMS APPLY AS THIS ADVERSE EVENT DID NOT MEET THE CRITERIA FOR MEDICAL DEVICE ADVERSE EVENT REPORTING. AS A RESULT, SERIOUS INJURY WAS SELECTED FOR THIS FIELD.

    Description of Event or Problem · 0

    A 69-YEAR-OLD FEMALE PATIENT WITH PUNCTATE KERATITIS / DRY EYE DISEASE HAD PROKERA SLIM (PKS) PLACED ON HER LEFT EYE ON (B)(6) 2025 BY OPTOMETRIST (OD) DR. (B)(6) AFTER UNEVENTFUL USE OF PKS IN THE RIGHT EYE. MIDDAY ON (B)(6) 2025 THE PATIENT EXPERIENCED A SUDDEN ONSET OF SEVERE PAIN ACCOMPANIED BY BROWNISH DRAINAGE. THE PATIENT RETURNED TO CLINIC THAT SAME DAY. THE EYE WAS EXAMINED PRIOR TO DEVICE REMOVAL; THE DEVICE WAS BOTH STILL INTACT AND CORRECTLY POSITIONED. THE DEVICE WAS THEN REMOVED; IT WAS NOTED THAT THE AMNIOTIC MEMBRANE WAS DISSOLVING BUT WAS CURRENTLY IN PLACE. A THOROUGH EXAM WAS THEN CONDUCTED NOTING THAT THE PATIENT HAD SOME CHEMOSIS (SWELLING OF EYE SURFACE MEMBRANES) AND INJECTION (REDNESS). THERE WERE NO SIGNS OF ABRASION OR ANY INJURY TO VIEW. THE PATIENT NOTED THAT IN HER OPINION, BOTH THE INSERTION AND REMOVAL OF THE PKS DEVICE WERE WITHOUT ISSUE OR INJURY. ON HER WAY HOME FROM THIS APPOINTMENT, THE PATIENT THEN DEVELOPED A SUBCONJUNCTIVAL HEMORRHAGE WHICH SHE NOTED ECLIPSED HER VISION (BLURRY VISION ECLIPSED WITH RED). SHE ALSO REPORTED "A DARK, TENDER, SWOLLEN AREA DEVELOPED BELOW THE EYE WITH SWELLING AND ERYTHEMA (SKIN REDNESS) ON THE LATERAL EDGE." THE PATIENT CLAIMS SHE DID NOT RUB HER EYE OR EXPERIENCE ANY OTHER EYE TRAUMA DURING THE WEARING OF THE DEVICE. THE PATIENT ALSO NOTES NO STRAIN, COUGH OR SNEEZE HAVING OCCURRED PRIOR TO ONSET AND NO RUBBING OF THE EYE ON THE RIDE HOME. THE PATIENT IMMEDIATELY RETURNED TO CLINIC. THE OPTOMETRIST THEN PERFORMED ANOTHER EXAMINATION. THE PATIENT'S EYE WAS CLEAR WITH 360° SUB-CONJUNCTIVAL HEMORRHAGE AND WHAT WAS TERMED "TRAUMATIC IRITIS" ALONG WITH +1 INFLAMMATORY CELLS. THE CORNEA WAS NOTED TO HAVE "LOOKED GREAT." THE DOCTOR STATES HE USED THE TERM TRAUMATIC IRITIS AS HE ASSUMED IT WAS TRAUMA BY THE RING (DOCTOR USES IRITIS AND UVEITIS INTERCHANGEABLY IN DIFFERENT COMMUNICATIONS). THE PATIENT REPORTED NO TRAUMA OCCURRING. TREATMENT AS RESULT OF EVENT: THE PATIENT WAS PUT ON PROPHYLACTIC ANTIBIOTIC DROPS (MOXIFLOXACIN 4X DAILY), ANTIBIOTIC OINTMENT (BACITRACIN/POLYMYXIN 2X DAILY) AND ORAL ANTIBIOTICS (CEPHALEXIN 4X DAILY), AS WELL AS STEROID DROPS (PREDNISOLONE EVERY 2 HOURS) ON (B)(6) 2025. THE PATIENT WAS SEEN BY DR. (B)(6) FOR FOLLOW-UP ON (B)(6) 2025, AT WHICH TIME IMPROVEMENTS WERE NOTED, ALTHOUGH HE CONTINUED TO NOTE SUB-CONJUNCTIVAL HEMORRHAGE, CHEMOSIS, UVEITIS AND PAIN (PATIENT DID NOT EXPRESS PAIN AT THIS TIME IN HER REPORT). DUE TO THERE BEING NO SIGNS OF INFECTION, THE DOCTOR INSTRUCTED THE PATIENT TO STOP ALL TOPICAL ANTIBIOTICS BUT HAD HER CONTINUE ON THE ORAL ANTIBIOTICS AS SHE'D ALREADY STARTED THE COURSE. SHE WAS KEPT ON THE STEROID DROPS TO TAPER OFF. THE PATIENT'S CORNEA WAS NOTED BY DR. (B)(6) TO "LOOK GREAT." AS OF (B)(6) 2025, PATIENT NOTED SHE STILL HAD OCULAR REDNESS, BUT DID NOT NOTE OTHER SIGNS/SYMPTOMS. UPDATE FROM PATIENT ON (B)(6) 2025 INDICATED ALL PERIORBITAL REDNESS AND EDEMA HAD RESOLVED. THE EYE REMAINS BLOODSHOT IN AREAS BUT IS IMPROVING AND VISION IS UNIMPAIRED. NON-SERIOUS INJURY: THERE WERE NO LASTING IMPAIRMENTS AND TREATMENTS ADMINISTERED WERE NOT REQUIRED TO PREVENT/PRECLUDE DAMAGE OR IMPAIRMENT (B)(6) 2024 FOLLOW-UP VISIT - PATIENT'S VISION WAS REPORTED TO BE 20/20 BILATERALLY (WITH CORRECTION). INTERNAL OCULAR PRESSURE (IOP) WAS 11MM HG BILATERALLY (NORMAL). SLIT LAMP EXAM FINDINGS WERE REPORTED TO BE "WAY BETTER" WITH IRITIS COMPLETELY RESOLVED, SUBCONJUNCTIVAL HEMORRHAGE BEING 90% RESOLVED WITH NO CHEMOSIS OR CORNEAL EDEMA. THE CORNEA "LOOKED GREAT" WITH TRACE SPK NOTED IN THE LEFT EYE. DR. (B)(6) BELIEVES THIS IS A RESULT OF HER HAVING DISCONTINUED USE OF THE VEVYE IN THIS EYE. THE RIGHT EYE SHOWED NO SPK AND PT HAD BEEN USING VEVYE 2X DAILY IN THIS EYE. THE PT REPORTED FEELING "FINE" BUT CONCERNED ABOUT SUBCONJUNCTIVAL HEMORRHAGE TAKING LONG TO RESOLVE. DR. STATED IT WILL SELF-RESOLVE WITHOUT TREATMENT. THE PATIENT WAS ADVISED BY DR. (B)(6) TO RESUME VEVYE 2X DAILY AND PFATS 3-4X DAILY IN BOTH EYES. DR. (B)(6) EXAMINED THE PATIENT FOR CONJUNCTIVOCHALASIS (CCH) AND THERE WERE NO PROMINENT SIGNS OF CCH IN EITHER EYE. NOTES THAT BOTH EYES WERE SYMMETRICAL. THE PROKERA SLIM PRODUCTION AND COMPLAINT HISTORY ASSOCIATED WITH LOT TGRV24E007 WERE REVIEWED. THE PRODUCTION RECORDS INDICATE NO ABNORMALITIES OR DEVIATIONS IN THE PRODUCTION OF THESE UNITS. 49 UNITS OF PROKERA WERE PRODUCED. ALL UNITS HAVE BEEN DISTRIBUTED WITH NO REPORTED COMPLAINTS OR OTHER ADVERSE EVENTS. SOME PATIENTS WILL BE MORE SENSITIVE TO THE PRODUCT THAN OTHERS; NOT ALL PATIENTS WILL BE ABLE TO TOLERATE THE DEVICE FOR A VARIETY OF REASONS (FIT, POOR CENTRATION/DEVICE MOVEMENT, PATIENT SENSITIVITY, ETC.), AND MAY PRESENT AS GENERAL DISCOMFORT, BURNING, TEARING, OR OTHER MILD SYMPTOMS. THE PROKERA PRODUCT IS A RIGID DEVICE PLACED ON THE OCULAR SURFACE IN LIEU OF MORE INTRUSIVE SURGICAL PLACEMENT OF AMNIOTIC MEMBRANE. SUCH SYMPTOMS ARE TYPICALLY TRANSIENT AND RESOLVE WITH DEVICE REMOVAL. THE PRODUCT INSERT ADDRESSES THIS ISSUE WITH THE STATEMENT: "IF THE PATIENT CANNOT TOLERATE WEARING PROKERA, THE DEVICE SHOULD BE REMOVED". POOR CENTRATION IS A COMMON CAUSE OF DISCOMFORT WITH THE USE OF PROKERA. TARSORRHAPHY IS RECOMMENDED IN THE PRODUCT INSERT TO SECURE THE DEVICE AND WAS USED IN THIS CASE, BUT PATIENTS MAY STILL EXPERIENCE SOME FRICTION/MOVEMENT ON THE EYE. THE SUDDEN ONSET OF PAIN AND BROWNISH DISCHARGE SUGGEST AN EVENT OCCURRED WHICH WAS MORE SIGNIFICANT THAN PATIENT SENSITIVITY. AS THE DEVICE IS REPORTED TO HAVE BEEN INTACT AND IN PROPER PLACEMENT (CENTERED), IT IS UNCLEAR WHAT CAUSED THIS SUDDEN ONSET OF PAIN. POSSIBLE CAUSES OF SUDDEN EYE PAIN AND EXCESSIVE DISCHARGE ARE NUMEROUS AND INCLUDE SUCH FACTORS AS OCULAR TRAUMA, INFECTION AND INFLAMMATION. NO INFECTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223608 PROKERA PROKERA SLIM NQB BIOTISSUE HOLDINGS INC. PKS TGRV24E007

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other ADTHYZA 60MG/DAY.| IBUPROFEN 200MG (AS NEEDED).| VEVYE EYE DROPS.