MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,company representati report with the FDA on 2015-06-30 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[6042240]
A facility employee reported that a system shut down while a surgeon was implanting a toric intraocular lens (iol). No action was performed. Additional information has been requested but not received to date. This is one of two reports being filed for this facility. This report is for a pool of patients.
Patient Sequence No: 1, Text Type: D, B5
[13306789]
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 but not received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28446456]
Evaluation summary:sample was not returned. 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. Reported issue could not be reproduced by the fse on site. After performing data collection to free up memory space, the issue was never recognized.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00507 |
| MDR Report Key | 4877644 |
| Report Source | 00,01,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-30 |
| Date of Report | 2015-10-16 |
| Date Mfgr Received | 2015-10-02 |
| Device Manufacturer Date | 2013-12-05 |
| Date Added to Maude | 2015-07-27 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2015-06-30 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | 2.5.1 |
| 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 | 2015-06-30 |