MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-26 for KAMRA INLAY 76225 manufactured by Corneagen.
[115188764]
Mdr was initially sent via cd. Cd was rejected and returned to corneagen. We became aware of this earlier today ((b)(6) 2018). Submitting via emdr now. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[115188765]
Kamra inlay was explanted from patient due to reported induced astigmatism caused by epithelial ingrowth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2018-00002 |
| MDR Report Key | 7724395 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date of Event | 2018-05-03 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2018-07-26 |
| 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 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAMRA INLAY |
| Generic Name | KAMRA |
| Product Code | LQE |
| Date Received | 2018-07-26 |
| Returned To Mfg | 2018-06-12 |
| Model Number | 76225 |
| Lot Number | A635-0317 |
| 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 27101 US 27101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-26 |