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 2019-04-04 for KAMRA INLAY manufactured by Corneagen.
[140924702]
The surgeon/surgical team discarded the inlay post explant and did not return it to corneagen quality assurance. It is also important to note that the pocket depth of the implant was 130 micrometers. This is extremely shallow. Implants are supposed to be closer to 250 if not at or approaching 300 micrometers in depth.
Patient Sequence No: 1, Text Type: N, H10
[140924703]
Patient complained of haze and decreased visual acuity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2019-00001 |
| MDR Report Key | 8483395 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2019-04-04 |
| 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 | 2019-04-04 |
| Lot Number | A629-1016 |
| Device Expiration Date | 2018-10-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-04 |