FDA Adverse Event Injury Summary report: N

PROKERA SLIM NON-STERILE BIOLOGICAL CORNEAL BANDAGE

MDR report key: 22034928 · Received May 16, 2025

Report

Report Number
MW5170455
Event Type
Injury
Date Received
May 16, 2025
Report Date
May 14, 2025
Manufacturer
TISSUETECH, INC. / BIOTISSUE HOLDINGS, INC.
Product Code
NQB
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD DRYNESS AND MUCUS BALLS EVERYDAY ON MY EYES. MY EYE DOCTOR TREATED IT WITH BANDAGE LENSES AND GAVE ME A STEROID EYE DROP. THE STEROID EYE DROPS MADE MY EYE CONDITION WORSE. BUT SECOND TIME BANDAGE LENSES, HE SAID ALL GOT BETTER. AND THEN HE GAVE MY TWO OPTIONS, I JUST BECAME A FULL TIME CONTACT LENS WEARER. (I NEVER WORE CONTACT LENSES BEFORE.) I CAN DO EMBRYONIC DISC LENS THAT IS HEALING LENS. SO I DID THE HEALING LENS ON MY RIGHT EYE. APRIL 27TH. SUNDAY EVENING: TAKE DISC LENS OUT ON RIGHT EYE. AFTER TAKE THE HEALING LENS OUT, MY RIGHT EYE IS REALLY RED, A HALF BLINDED BLURRY, VERY SENSITIVE TO LIGHTS, INFLAMMATION, THE MEMBRANE MADE A MARKING ON MY CORNEA, AND EDEMA. THE DOCTOR DILATED MY EYE. HE SAID HE PUT SOMETHING ON MY EYE THAT MAKES DILATION GOES FOR A WEEK. AND FOR MY READING EYE VISION, AFTER ALL LENSES ARE OUT, MY DISC EYE IS COMPLETELY BLINDED, AND THE OTHER EYE IS A BIT OUT OF FOCUS EVEN WITH GLASSES ON. APRIL 29TH: THE DOCTOR SAID THAT MY DISC EYE STILL HAS INFLAMMATION, CORNEA IS SWELLED AND HAS EDEMA. IN ABOUT 1-2 WEEKS, MY BLURRY WILL BE ALL OF SUDDEN GET CLEARED. AND HE SAID, HIS TREATMENT WENT OPPOSITE OF HEALING DRYNESS. APRIL 30TH: THE DISC EYE HAS STILL BLURRINESS AND STILL DILATED. DR. (B)(6) TOLD THE STUDENT DOCTOR, ¿THE DOCTOR (DR. (B)(6)) CAUSED SOMETHING!¿, AND ON LEFT EYE, A BIT OF TIREDNESS, A BIT OF REDNESS. MAY 4TH: LEFT EYE: 1 MUCUS BALL. RIGHT EYE: THE DOCTOR TOLD ME EARLIER DAY THAT HE TRIED THE DISC LENS ON 4 PEOPLE. ALL FAILED. THE LENS IS APPROVED BY FDA. MAY 5TH: LEFT EYE: WHEN I WAKE UP, EYE FEELS DRIED UP AND A BIT RED. IT FEELS LIKE BANDAGE LENS 3 TIMES ON EYE MADE IT WORSE AS WELL. RIGHT EYE STILL DILATED. DOCTOR SAID THAT IT¿LL BE NORMAL IN 4-5 DAYS. HE SAID THAT DRYNESS ON BOTH EYE ARE AS DRY AS BEFORE ANY TREATMENTS (LENSES). THE DOCTOR RECOMMEND, PROKERA SLIM. PUNCTAL PLUGS. MAY 8TH: BOTH EYES: VERY RED, AND VERY IRRITATED ALL DAY. THE EYE CONDITION IS WORSE THAN BEFORE ANY TREATMENTS WITH LENSES. IT WAS ONLY DRY TIME TO TIME BEFORE, NOT ALL DAY EVERY DAY. EYE VISION: WITH GLASSES ON: READING BOOK: THE RIGHT EYE IS SHARPER THAN THE LEFT EYE NOW. SOMEHOW TODAY: THE LEFT EYE WAS VERY CLEAR BEFORE, BUT TODAY A BIT BLURRY. IN DISTANCE: THE RIGHT EYE IS A BIT BLURRY AND THE LEFT EYE CAN SEE IT BETTER THAN RIGHT EYE. MAY 10TH: BOTH EYES: IT IS FIRST MORNING MY EYES FEEL SOMEWHAT NORMAL. THE VISION FEELS SOMEWHAT NORMAL. EYE CONDITION FEELS SOMEWHAT NORMAL. THEY ARE A BIT PINKISH. MY RIGHT EYE STILL A BIT OF DARKER SHADE OF COLOR THAN LEFT EYE BECAUSE OF THE DISC LENS. I HAVE TO MAKE SURE ABOUT THERE STILL IS MEMBRANE MARKING ON CORNEA, AND THE EYE STILL LOOKING LIKE SNOWBALL SHOOK, AS THE DOCTOR SAID WHEN HE TOOK OUT THE LENS 13 DAYS AGO. THERE IS A WHITE DOT ON LEFT EYE BELOW PINGUECULA, THAT I DIDN¿T NOTICE BEFORE TREATMENTS. ALSO RIGHT EYE, RIGHT SIDE OF PUPIL, I SEE A WHITE DOT ON THAT AS WELL. A MUCUS BALL ON RIGHT EYE THIS MORNING. MAY 11TH: 2 WEEKS SINCE DISC LENS OUT: REDNESS AND IRRITATION A LOT BETTER ON BOTH EYES; WHITE PART OF RIGHT EYE HAS SOME MUCH OF DARKER SHADE OF COLOR THAN LEFT; ALL VISION: LEFT EYE IS A BIT SHARPER, ONLY EXCEPT THE TIME WHEN I LOOK AT BOOK WITH GLASSES ON, THE RIGHT EYE A BIT SHAPER THAT TIME; I SEE A WHITE SPOT ON LEFT EYE BELOW PINGUECULA THAT IS ON THE MIDDLE ON INNER SIDE. MAY 13TH: VISION: READING A BOOK WITH GLASSES ON: IT LOOKS SHARPER WHEN I LOOK AT THE BOOK WITH LOOKING AT BOTTOM PART OF GLASSES, NOT MIDDLE PART. IT FEELS LIKE MY NEW GLASSES FROM LAST DECEMBER GOT NO GOOD. WALMART READING GLASSES IS SHARPER FOR READING TODAY. LEFT AND RIGHT EYES VISION JUST ABOUT SAME TODAY. I SAW SOME MUCUS BALLS YESTERDAY. REF REPORT: MW5170456.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2190907 PROKERA SLIM NON-STERILE BIOLOGICAL CORNEAL BANDAGE CONFORMER, OPHTHALMIC, BIOLOGICAL TISSUE NQB TISSUETECH, INC. / BIOTISSUE HOLDINGS, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown