MAUDE Adverse Event Report: TISSUETECH INC PROKERA; CONFORMER, OPHTHALMIC BIOLOGICAL TISSUE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Type  Injury  

Event Description

I have a recurring corneal abrasion that has gotten more frequent in the past few months.Numerous eye drops and thinking i was going to have this problem for life i was very pleased when my new eye dr suggested i try a lens that fits over my eye made from amniotic membranes, it was called prokera, i had it placed on friday july 26th in the afternoon, it irritated my eye a little and caused some blurriness and eye watering but i knew that was to be expected.The following morning, my eye was swollen shut, matted and red.I was not able to open it at all and even had trouble keeping my other eye open from the strain.By that evening i had developed cold chills and was dry heaving.I had to stay in my bedroom with the curtains closed and the room as dark as possible.My eye socket and cheekbone felt like it had been hit with a hammer.I had never been in such pain.The next day my eye doctor met me in his office after my mother had to drive me there.He took one look at my eye that i could not open on my own and then took the lens out.The initial burning taking it out lasted just a few seconds and then after a few drops it was pure relief.It has now been 3 days since the lens had been removed, the redness is almost gone only a little dryness is left.I have looked in a lot of places but have not seen any side effects like i have had associated with this.Fda safety report id # (b)(4).

• Brand Name: PROKERA
• Type of Device: CONFORMER, OPHTHALMIC BIOLOGICAL TISSUE
• Manufacturer (Section D): TISSUETECH INC
• MDR Report Key: 8860231
• MDR Text Key: 153684179
• Report Number: MW5088720
• Device Sequence Number: 1
• Product Code: NQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 91