MAUDE Adverse Event Report: CORNEAGEN KAMRA INLAY

Model Number 76043

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Corneal Clouding/Hazing (1878)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Conversation between qa and director of medical affairs to determine reportability and cause.Conclusion to report and cause likely due to patient management and dry eye.E-mail chain in reverse chronological order."hi (b)(6), corneal nerves are severed during pocket creation and flap creation if it is a combined procedure.I think dryness may be more of a culprit of the sensations than anything else.The other factor that is worth considering is that the patient is what we call a 'steroid responder' - that means that their intraocular pressure elevates after they use steroid drops - this may cause some swelling and even possible haze in the cornea - so whatever they had noted may not necessarily have been inlay related.There are a lot of factors to consider here other than haze - i am with you in that haze may have been a byproduct of what was originally going on and how the patient was managed.Hope that helps.(b)(6), o.D.Director of medical affairs | clinical education.(b)(6), corneagen, (b)(4).On may 29, 2019, at 6:13 am, (b)(6) wrote: (b)(6), i'll report it since you support that idea.I'm hesitant to mark it as haze related, though, as all the complaints seem to be "blurry", "scratchy", or "headache" almost as a function of the pt feeling the kamra in her eye.I don't know if that's really possible.What are the chances the pt had nerve endings close the implant, or that the surgery might have disrupted placement of the endings? thanks, (b)(6).Quality assurance coordinator (b)(6).(b)(4).From: (b)(6).Sent: tuesday, may 28, 2019 10:31 pm.To: (b)(6).Subject: re: kamra removals.Hi (b)(6), i believe so, what do you think? (b)(6), o.D.Director of medical affairs | clinical education.(b)(6).Corneagen (b)(4).On may 28, 2019, at 7:55 am, (b)(6) wrote: (b)(6), now that we have some more information, do you still feel it is right to report the haze case? thank you, (b)(6).".

Event Description

Surgery center first reported as "patient complained of blurry vision, pain etc.Haze os first noted on (b)(6) 2018 '2+ haze'." further follow up: "the patient noted on (b)(6) 2019- "va fluctuation, stinging, pressure." on (b)(6) 2019 "pt feels she still gets headaches".On (b)(6) 2019- "still gets headache with os".On (b)(6) 2018- os always feels like fb.Pt gets headaches to os blurry".On (b)(6) 2017- complains of scratchy, itchy".On (b)(6) 2016- "feels like something is in eye, feels scratchy/itchy".Surgery was on (b)(6) 2016.The patient consistently had blurry vision in the eye, despite artificial tears, durezol, restasis etc.And it led to constant headaches.Patient complained of fb sensation thru the time she had the inlay.".

• Brand Name: KAMRA INLAY
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem NC 27101
• Manufacturer (Section G): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem NC 27101
• Manufacturer Contact: benjamin steinberg ; 101 n. chestnut st.; ste. 303; winston salem, NC 27101 ; 3365169640
• MDR Report Key: 8658108
• MDR Text Key: 146641237
• Report Number: 3005357288-2019-00005
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 76043
• Device Lot Number: A570-0715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 59