MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2009-10-01 for KERASPEAR EYE SPEAR 410101 manufactured by Medtronic Xomed, Inc..
[1177885]
The customer reported to medtronic that a patient developed dlk (diffuse lamellar keratitis) after the doctor used the keraspear. The customer is not sure which lot number was used in the procedure. The source of the dlk is uncertain, and the customer was inquired if there have been other reports. The lasik procedure occurred in 2009. The patient is fine. The customer indicated that they are not sure if the event is related to the spears, and that it could have been anything (air quality, air flow, tool handle, and glove).
Patient Sequence No: 1, Text Type: D, B5
[8368489]
An evaluation of the device performance was not possible as no sample was returned for analysis. The customer's purchase history indicated that they received three different lots. Evaluation of devices from the three lots was not possible as all units have distributed. The device history records were reviewed and no anomalies were indicated. The cause is unknown. Medical knowledge of dlk indicates that it was an enigmatic problem when it was first discovered, and is still not completely understood. It is known that dlk tends to occur in "runs" of several patients in a row, and that there are several possible causes or that multiple conditions must exist for dlk to occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2009-00044 |
| MDR Report Key | 1489955 |
| Report Source | 00,05,06 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-03 |
| Date of Event | 2009-02-01 |
| Date Mfgr Received | 2009-09-03 |
| Date Added to Maude | 2009-11-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERASPEAR EYE SPEAR |
| Generic Name | HOZ - SPONGE, OPHTHALMIC |
| Product Code | HOZ |
| Date Received | 2009-10-01 |
| Model Number | 410101 |
| Catalog Number | 410101 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-10-01 |