FDA Adverse Event Injury Summary report: N

PROKERA

MDR report key: 21826591 · Received April 11, 2025

Report

Report Number
MW5168899
Event Type
Injury
Date Received
April 11, 2025
Date of Event
April 4, 2025
Report Date
April 7, 2025
Manufacturer
BIOTISSUE HOLDINGS INC.
Product Code
NQB
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

MY OPTOMETRIST PRESCRIBED A PROKERA TREATMENT FOR DRY EYE. MY RIGHT EYE WAS TREATED WITHOUT PROBLEMS PRIOR TO THE INCIDENT REPORTED HERE. ON FRIDAY (B)(6) 2025, THE LENS INSERTED IN THE LEFT EYE (ON (B)(6) 2025) VERY SUDDENLY BECAME EXTREMELY PAINFUL, WITH COPIOUS DRAINAGE POURING DOWN MY FACE. I MADE AN URGENT APPOINTMENT WITH MY OPTOMETRIST WHO REMOVED THE LENS. WHILE DRIVING HOME, I DEVELOPED A LARGE SUBCONJUNCTIVAL HEMORRHAGE SUDDENLY ECLIPSING INCLUDING MY VISION, I TURNED RIGHT AROUND AND DROVE BACK TO THE DOCTOR'S OFFICE HALF BLIND. I WAS ALSO RAPIDLY DEVELOPING A DARK, TENDER, SWOLLEN AREA BELOW MY EYE AND SWELLING AND ERYTHEMA ON THE LATERAL EDGE. THE DOCTOR DID AN EVALUATION OF MY EYE & I WAS PRESCRIBED ORAL ANTIBIOTICS, TWO TYPES OF OPHTHALMIC ANTIBIOTICS, AND AN OPHTHALMIC STEROID. BEFORE I WENT TO BED THAT NIGHT, THE SUBCONJUNCTIVAL HEMORRHAGE COMPLETELY COVERED MY EYE ALL THE WAY UP TO MY PUPIL ALMOST COMPLETELY INCLUDING MY IRIS AND CORNEA. NEVER IN THE PROCESS DID I FEEL LIKE THE DOCTOR DID ANYTHING TRAUMATIC IN INSERTION OR REMOVAL OF THE LENS. I DIDN'T HAVE ANY PROBLEMS WITH IT AT ALL, AND IN FACT HAD ALREADY HAD A POSITIVE EXPERIENCE A COUPLE OF DAYS BEFORE WITH MY RIGHT EYE. THIS WAS A VERY DISTURBING SITUATION, AND I FEEL LIKE IT MUST BE SOMETHING TO DO WITH THE MANUFACTURING OF THE LENS OR SOMETHING LIKE THAT BECAUSE NOTHING ELSE WAS AMISS. OTHERWISE, HEALTHY, NO HYPERTENSION HIGH LIPIDS, DIABETES OR OTHER PROBLEMS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
121754 PROKERA CONFORMER, OPHTHALMIC, BIOLOGICAL TISSUE NQB BIOTISSUE HOLDINGS INC.

Patients

Seq Age Sex Outcome Treatment
1 69 YR Female Required Intervention BACITRACIN/POLYMYX 3.5G BID| ACETATE 1% 1 DROP EVERY 2 HOURS FOR 5 DAYS| ALSO ADTHYZA 60MG/DAY FOR THYROID. | CEPHALEXIN 250MG BY MOUTH QID.| IBUPROFEN 200MG PRN, I HAD TAKEN ONE DOSE DURING THE RIGHT EYE PROKERA TREATMENT 2 DAYS PRIOR TO INSERTION OF THE LEFT EYE PROKERA.| MOXIFLOZACIN 0.5% QID| PREDNSOL ONE| VEVYE EYE DROPS (BUT NOT USED DURING PROKERA TREATMENT IN EITHER EYE).