MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-21 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[43279551]
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
[43279552]
A doctor reported that toric intraocular lens implanted in a patient's right eye was misaligned by 90 degrees one day post cataract surgery. Diagnostic imaging system was used during the implantation. At one day follow up, patient was taken back into the operating room and lens was repositioned.
Patient Sequence No: 1, Text Type: D, B5
[45285178]
Patient Sequence No: 1, Text Type: N, H10
[50654539]
No anomalies were found by review of device history record. The product met all specifications when released. There are two possible scenarios for root causes for a rotated lens by 90 degrees which are both use errors. An incorrect doctor seating position selection may result in a wrong displayed axis shown in the overlay - use error. The second scenario is that the user has selected the simplified overlay which shows only the steep and flat axis. The user then might have oriented the lens according the wrong axis shown in the overlay - use error. The root cause cannot be determined conclusively. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00017 |
| MDR Report Key | 5596685 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-21 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-07-01 |
| Date Added to Maude | 2016-04-21 |
| 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 | 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 | 2016-04-21 |
| 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 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-04-21 |