MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[38772326]
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. Additional information has been requested. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38772327]
A surgeon reported an alignment jump with the system. This resulted in a misalignment of the intraocular lens (iol). Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[41231185]
Data collection for investigation requested and not received. No anomalies found by review of device history record. Product met all specifications when released. No technical root cause could be determined as the system is performing within specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00004 |
| MDR Report Key | 5433889 |
| Date Received | 2016-02-12 |
| Date of Report | 2016-03-25 |
| Date Mfgr Received | 2016-03-05 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2016-02-12 |
| 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 | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2016-02-12 |
| Model Number | X-SPM |
| Catalog Number | 8065998243 |
| Lot Number | ASKU |
| ID Number | 00380659982439 |
| 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 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-12 |