MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for VERION REFERENCE UNIT X-RUP 8065998240 manufactured by Wavelight Gmbh (agps).
[39417521]
No anomalies found by review of device history record. Product met all specifications when released. An internal investigation has been initiated by the manufacturer for this reported issue. Software functionality is under review, for planning of treatment of non-company manufactured lenses, to understand the introduction of unintended arcuate/limbal relaxing incisions by way of inadvertent activation of a function when user clicks dedicated items in treatment planning. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39417522]
A surgeon reported after planning for laser assisted cataract surgery without arcuates, the data was transferred showing arcuates that could not be turned off or modified. The cases were completed without the use of the planning device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300699-2016-00007 |
| MDR Report Key | 5459017 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-01-25 |
| Date Mfgr Received | 2016-02-15 |
| Date Added to Maude | 2016-02-24 |
| 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 | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELOW BERLIN 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 | 0 |
| Brand Name | VERION REFERENCE UNIT |
| Generic Name | KERATOMETER, PUPILLOMETER |
| Product Code | FTH |
| Date Received | 2016-02-24 |
| Model Number | X-RUP |
| 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 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-24 |