MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-05-31 for KAMRA INLAY 76043 manufactured by Corneagen.
[146641237]
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
Patient Sequence No: 1, Text Type: N, H10
[146641238]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2019-00005 |
| MDR Report Key | 8658108 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2019-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BENJAMIN STEINBERG |
| Manufacturer Street | 101 N. CHESTNUT ST. STE. 303 |
| Manufacturer City | WINSTON SALEM NC 27101 |
| Manufacturer Country | US |
| Manufacturer Postal | 27101 |
| Manufacturer Phone | 3365169640 |
| Manufacturer G1 | CORNEAGEN |
| Manufacturer Street | 101 N. CHESTNUT ST. STE. 303 |
| Manufacturer City | WINSTON SALEM NC 27101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAMRA INLAY |
| Generic Name | KAMRA INLAY |
| Product Code | LQE |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-05-06 |
| Model Number | 76043 |
| Lot Number | A570-0715 |
| Device Expiration Date | 2017-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORNEAGEN |
| Manufacturer Address | 101 N. CHESTNUT ST. STE. 303 WINSTON SALEM NC 27101 US 27101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-31 |