MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-17 for VERION DIGITAL MARKER M X-SPM 8065998242 manufactured by Wavelight Gmbh (agps).
[83128154]
Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83128155]
A surgeon reported; after implantation of the intraocular lens during image guided cataract surgery it was found that the system marker shows the implantation axis at two degrees. The surgeon reviewed the treatment plan and found the axis should be at eleven. After reboot of the system the marker displayed the correct axis which aligned with the data print out. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[113535349]
No anomalies found by review of device history record. Product met all specifications when released. Based on the provided data collection of this case a user error can be confirmed. The initial surgical plan shows the reported 11? As implantation axis. However based on the provided data, on the planning screen the implantation axis was manually changed to 2?. Accordingly these 2? Have been shown during surgery as implantation axis. The field service engineer was on site and retrained the customer relating to these issues. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00025 |
| MDR Report Key | 6802020 |
| Date Received | 2017-08-17 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-08-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NADIA BAILEY |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| Manufacturer Phone | 8176152230 |
| 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 | 0 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2017-08-17 |
| Model Number | X-SPM |
| Catalog Number | 8065998242 |
| Lot Number | ASKU |
| ID Number | 00380659982422 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-08-17 |