FDA Adverse Event Injury Summary report: N

PROKERA

MDR report key: 24474720 · Received February 27, 2026

Report

Report Number: 3009809074-2026-00002
Event Type: Injury
Date Received: February 27, 2026
Date of Event: January 5, 2026
Report Date: February 27, 2026
Manufacturer: BIOTISSUE HOLDINGS INC.
Product Code: NQB
PMA / PMN Number: K032104
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE MDR WAS SUBMITTED BEYOND THE 30-DAY TIMEFRAME FOLLOWING POST-INVESTIGATION CLARIFICATION OF REPORTABILITY CRITERIA IDENTIFIED DURING AN FDA INSPECTION. IT WAS DETERMINED THAT EVENTS INVOLVING MEDICAL TREATMENT AFTER DEVICE USE, EVEN IN THE ABSENCE OF A CONFIRMED SERIOUS INJURY, SHOULD BE CONSIDERED INTERVENTIONS TO PRECLUDE SERIOUS INJURY AND THEREFORE REPORTABLE. THE RECORD WAS RE-EVALUATED ACCORDINGLY, AND AN MDR WAS SUBSEQUENTLY FILED.

Description of Event or Problem · 0

EVENT WAS INITIALLY REPORTED BY THE TREATING PHYSICIAN TO A BIOTISSUE MEDICAL SCIENCE LIAISON ON (B)(6) 2026. PROKERA SLIM DEVICE WAS PLACED ONTO PATIENT'S EYE ON (B)(6) 2026, FOR TREATMENT OF DRY EYE DISEASE AND NEUROTROPHIC KERATITIS (NK) WITH REDUCED CORNEAL SENSITIVITY. NO ISSUES WERE REPORTED AT TIME OF INSERTION. THE PATIENT RETURNED TO CLINIC THE SAME AFTERNOON, APPROXIMATELY 4 HOURS AFTER PRODUCT PLACEMENT, COMPLAINING OF INTENSE OCULAR PAIN. THE DEVICE WAS REMOVED BY THE PHYSICIAN. CLINICAL EXAM NOTED THE CORNEA WAS "SCRATCHED UP" AND INFLAMED WITH A CENTRAL ABRASION OBSERVED. SOME (UNSPECIFIED) VISUAL ACUITY LOSS WAS NOTED. PATIENT WAS TREATED WITH TOPICAL STEROID DROPS. PATIENT RETURNED TO OFFICE ON 08JAN2026 SYMPTOM FREE WITH NO REMARKABLE CLINICAL EXAM FINDINGS (RESOLVED).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
536297	PROKERA	PROKERA SLIM	NQB	BIOTISSUE HOLDINGS INC.	PKS	SM20230808

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR	Female	Required Intervention