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 2018-10-12 for KAMRA CORNEAL INLAY manufactured by Corneagen.
[123570675]
After visually inspecting the inlay and reviewing the dhr, visual acuity table, and circumstantial information about the case this incident is reportable to the fda. However, it is not possible to definitively say that the slow recovery time and ucva scores are due to the kamra inlay. The surgeon performed a secondary procedure involving a laser--a decision that is strongly cautioned against in the kamra inlay ifu--within a 24 hour period of re-centering a new inlay.
Patient Sequence No: 1, Text Type: N, H10
[123570676]
The patient had an initial inlay implanted. The doctor deemed it was off center and required recentration with another kamra inlay. The recentration was not effective and lead to continued visual problems with the patient. This lead to a permanent of explant of the inlay. It is noted that in this case, the patient was slow to recover. Also noted is that the patient went through topographic guided lasik/t-cat surgery within the same 24 hours; a process advised against in the ifu of kamra inlays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2018-00005 |
| MDR Report Key | 7961796 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2018-10-12 |
| 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 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 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 CORNEAL INLAY |
| Generic Name | KAMRA INLAY |
| Product Code | LQE |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-09-18 |
| Lot Number | A633-0317 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 17 MO |
| 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 27101 US 27101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |