MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for VERION REFERENCE UNIT X-RUS 8065998240 manufactured by Wavelight Gmbh (agps).
[54267637]
Evaluation summary: no sample is expected for evaluation. The device history records (dhr) for the device could not be performed, as the serial number was not provided by the reporter. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54267638]
An ophthalmologist reported that following toric intraocular lens (iol) implant surgery, four patients had an expected refractive outcome. All four patients were measured preoperatively with the reference unit. The outcome was due to the positioning of the iol axis being ten to fifteen degrees away from the intended position. There were no specific patient identifiers provided. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300699-2016-00037 |
| MDR Report Key | 5938004 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-09-08 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-08-15 |
| Date Added to Maude | 2016-09-08 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 14513 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | HLG |
| Date Received | 2016-09-08 |
| Model Number | X-RUS |
| Catalog Number | 8065998240 |
| Lot Number | ASKU |
| ID Number | 00380659982408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-08 |