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 2019-04-05 for KAMRA INLAY manufactured by Corneagen.
[141086747]
It is difficult to determine a root cause of the patient's negative visual acuity. From initial explant to the explant vision actually improved, but the time taken to do so was not to the patient's preference. Kamra inlays, in general, take a healing period physically to the corneal space as well as the psychologically and physiologically. It takes time for the brain to rewire nervous inputs from the eye to proper and expected perceptual vision. It is difficult to determine where in the process this patient was at time of explant and if the issue was physical or physiological.
Patient Sequence No: 1, Text Type: N, H10
[141086749]
Patient wanted the device removed; complaints assumed to be based on visual acuity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2019-00003 |
| MDR Report Key | 8488229 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2019-04-05 |
| 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 |
| 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 | 2019-04-05 |
| Returned To Mfg | 2019-03-25 |
| Lot Number | A629-1016 |
| Device Expiration Date | 2018-10-01 |
| 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. Required No Informationntervention | 2019-04-05 |