PROKERA

Additional Manufacturer Narrative

PRODUCT WAS DISCARDED BY THE FACILITY, THUS WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY FILE FOR THE ASSOCIATED PRODUCT LOT WAS CONDUCTED AND CONFIRMED THAT THE LOT WAS MANUFACTURED, PACKAGED AND RELEASED IN ACCORDANCE WITH ALL APPLICABLE SPECIFICATIONS AND PROCEDURES. A REVIEW OF COMPLAINT RECORDS IDENTIFIED NO OTHER COMPLAINTS OR ADVERSE EVENTS FOR THIS LOT HAVE BEEN REPORTED. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4). THIS MEDICAL DEVICE REPORT IS BEING SUBMITTED AS PART OF THE ACTIONS TAKEN BY BIOTISSUE HOLDINGS INC. (BTHI) IN RESPONSE TO FDA INVESTIGATOR FEEDBACK AND A 483 OBSERVATION RECEIVED 02/18/2026 REGARDING NOT SUBMITTING MDR REPORT WITHIN 30 DAYS OF BEING AWARE OF INFORMATION THAT REASONABLY SUGGESTED THAT A MARKETED DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS INJURY. DURING THE INSPECTION, FEEDBACK AND ADDITIONAL INFORMATION WERE PROVIDED REGARDING THE NEED TO INITIATE MDRS FOR ADVERSE EVENT CASES WHERE ANY MEDICAL OR SURGICAL TREATMENT WAS PROVIDED EVEN WHEN THE CAUSAL RELATIONSHIP TO THE DEVICE IS NOT EVIDENT, EVEN WHEN THE ADVERSE EVENT IS SELF-LIMITED, AND EVEN WHEN SUCH EVENTS MAY ARISE FROM UNDERLYING PATIENT CONDITIONS RATHER THAN DEVICE MALFUNCTION OR PERFORMANCE CONCERNS. THE FEEDBACK RECEIVED EXPANDED THE REPORTABILITY CRITERION BTHI WAS FOLLOWING BASED ON 21 CFR 803 REGULATION. AS BTHI IS FULLY COMMITTED TO COMPLIANCE WITH FDA REPORTING REQUIREMENTS, A RETROSPECTIVE REVIEW OF ADVERSE EVENTS SINCE THE LAST INSPECTION (MAR 2024) WAS COMPLETED. IN THIS LOOK BACK, ADVERSE EVENT CASES ALREADY INVESTIGATED AND DETERMINED NOT REPORTABLE WERE REASSESSED PER THE EXPANDED CRITERIA PROVIDED DURING THE INSPECTION THAT REDEFINED AS REPORTABLE CASES WHERE MEDICAL OR SURGICAL TREATMENT WAS PROVIDED, REGARDLESS OF CLINICAL OUTCOME OR RELATIONSHIP TO DEVICE PERFORMANCE. THE REVIEW IDENTIFIED ADVERSE EVENTS INVESTIGATED BETWEEN MARCH 2024 AND FEBRUARY 2026 THAT, UPON REASSESSMENT, MET THE EXPANDED CRITERIA FOR REPORTABILITY. THIS MDR SUBMISSION DATE FALLS OUTSIDE THE STANDARD 30-DAY REPORTING REQUIREMENT FROM THE AWARENESS DATE OF THE ADVERSE EVENTS AS THEY WERE IDENTIFIED REPORTABLE PER THE EXPANDED SCOPE AND CRITERIA RECEIVED POST-INSPECTION 02/18/2026.

Description of Event or Problem

ON (B)(6) 2024, A PHYSICIAN INSERTED A PROKERA CLEAR ONTO THE EYE OF A PATIENT FOR TREATMENT OF SUPERFICIAL PUNCTATE KERATITIS (SPK). THE DEVICE WAS REMOVED ON THE MORNING OF (B)(6) 2024 AS THE TREATMENT DURATION HAD COMPLETED. THERE WERE NO ISSUES REPORTED WITH THE EYE DURING TREATMENT (UNDERLYING ISSUE HAD RESOLVED). HOWEVER, DURING THIS VISIT, THE PATIENT REPORTED HAVING NOTED A RASH ON HER BOTTOM THE EVENING PRIOR (26SEP2024). LATER, IN THE EVENING OF (B)(6) 2024 AFTER THE PROKERA DEVICE HAD BEEN REMOVED, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) WITH AN ALLERGIC REACTION AND GOING INTO ANAPHYLACTIC SHOCK. ANY TREATMENTS OBTAINED AT THE ER WERE NOT NOTED. THE PATIENT HAS RESOLVED (DATE NOT SPECIFIED). THE TREATING PHYSICIAN STATED THEY DO NOT BELIEVE THE PROKERA DEVICE CAUSED OR CONTRIBUTED TO THE RASH OR ANAPHYLACTIC REACTION GIVEN THE TIMELINE OF ONSET COMPARED TO THE INSERTION/REMOVAL OF THE DEVICE (ALREADY OUT OF THE EYE WHEN REACTION OCCURRED).