MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[43032389]
Evaluation summary: 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43032390]
A surgeon reported that during surgery, the axis of the intraocular lens (iol) implantation moved approximately ten to fifteen degrees from the planned position. The condition of the patient is unknown. Although it was requested, the surgeon was unable to provide additional information. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
[44610390]
Evaluation summary: no anomalies found by review of device history record, product met all specifications when released. Product was not returned for investigation. Requested data were not provided for investigation. A jumping axis can have several causes. If the doctor selects the wrong doctor position, the device will not be able to register the correct angle. Poor illumination can also be a reason for not properly registering. The root cause of the event was attributed to user handling. The device will be removed from the site because of dissatisfaction of the surgeon.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00015 |
| MDR Report Key | 5568529 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-04-27 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2016-04-11 |
| 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 | 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 DIGITAL MARKER M |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2016-04-11 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | 2.6.0 |
| 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 | 2016-04-11 |