PROKERA SLIM (PKS)
Report
- Report Number
- 3009809074-2026-00029
- Event Type
- Injury
- Date Received
- May 19, 2026
- Date of Event
- April 23, 2026
- Report Date
- May 19, 2026
- Manufacturer
- BIOTISSUE HOLDINGS INC.
- Product Code
- NQB
- PMA / PMN Number
- K032104
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4). THE DEVICE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORTED EVENT; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED ALTHOUGH NO DEFECTS OR MALFUNCTIONS WERE REPORTED AS PART OF THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT'S ACCEPTANCE CRITERIA. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE EVENT. NO FURTHER ACTION WARRANTED AT THIS TIME.
A PHYSICIAN REPORTED THAT FOLLOWING A PROKERA SLIM PROCEDURE, THE PATIENT DEVELOPED CONJUNCTIVAL INJECTION, A CONJUNCTIVAL ABRASION, AND WORSENING OF THE PATIENT'S UNDERLYING CONDITIONS. A PROKERA DEVICE WAS INITIALLY PLACED ON (B)(6) 2026 FOR MANAGEMENT OF EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD) AND NEUROTROPHIC KERATITIS (STAGE 1) WITH SOME REPORTED PUNCTATE EPITHELIAL EROSION (PEE). THE EYE WAS TAPED FULLY CLOSED TO MINIMIZE DEVICE MOVEMENT ON THE EYE. NO FIT ISSUES, INSERTION DIFFICULTIES OR PATIENT-REPORTED PAIN/VISION CHANGES WERE NOTED. THE PATIENT SELF-REMOVED THE EYELID TAPE PRIOR TO FOLLOW-UP APPOINTMENT. THE PATIENT RETURNED FOR SCHEDULED DEVICE REMOVAL ON (B)(6) 2026, AT WHICH TIME IT WAS OBSERVED THAT THE PATIENT'S EBMD HAD EXTENDED TOWARD THE CENTRAL AXIS, AND CONJUNCTIVAL INJECTION (2+) AND A 1.5MM ROUND INFERIOR LIMBAL CONJUNCTIVAL ABRASION WERE NOW NOTED. T THE PATIENT WAS PRESCRIBED MOXIFLOXACIN ANTIBIOTIC DROPS FOUR TIMES DAILY AND ERYTHROMYCIN ANTIBIOTIC OINTMENT 4-6 TIMES DAILY AND ADVISED KEEPING THE EYELID CLOSED TO LIMIT SURFACE DISRUPTION. AT FOLLOW-UP ON (B)(6) 2026, THE PATIENT REMAINED ASYMPTOMATIC WITH MILD RESIDUAL REDNESS. EXAMINATION DEMONSTRATED IMPROVEMENT WITH CONJUNCTIVAL INJECTION REDUCED TO 1+, RESOLUTION OF PEE, EBMD APPEARANCE RETURNED TO BASELINE, AND A STABLE INFERIOR CONJUNCTIVAL ABRASION. ANTIBIOTIC THERAPY WAS ADJUSTED: MOXIFLOXACIN DROPS WERE REDUCED TO 2X DAILY FOR FIVE DAYS AND THEN DISCONTINUED. ERYTHROMYCIN OINTMENT WAS CONTINUED 4-6 TIMES DAILY FOR FIVE DAYS, FOLLOWED BY LONG-TERM NIGHTLY USE AND PRIOR TO NAPS FOR EBMD MANAGEMENT. AT LAST FOLLOW-UP, THE PATIENT'S CONDITION WAS IMPROVING. THE PATIENT PLANNED TO TRAVEL INTERNATIONALLY AND WOULD NOT RETURN TO THE UNITED STATES UNTIL AFTER (B)(6) 2026. SHE WAS INSTRUCTED TO SEEK LOCAL OPHTHALMIC CARE AND CONTACT HER PHYSICIAN IF SYMPTOMS WORSENED OR FAILED TO RESOLVE WITHIN ONE WEEK. FINAL RESOLUTION STATUS WAS NOT REPORTED. NO FURTHER UPDATES HAVE BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87515 | PROKERA SLIM (PKS) | OPHTHALMIC CONFORMER | NQB | BIOTISSUE HOLDINGS INC. | PKS | SM20242893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |