MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-03-31 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[41522096]
Sample was not returned. No information about the device or serial number was provided. No contact information provided; therefore, unable to obtain further follow up information. No technical root cause could be determined, based on the information provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41522097]
An ophthalmologist reported an intraocular lens (iol) axis was incorrectly aligned on an eye. Reporter indicated a secondary procedure was performed to relocate the iol to the correct axis. Additional information is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[48107940]
No information about the reported device was provided. No technical root cause could be determined, based on the information provided. Generally, an unstable overlay can be seen if illumination is too dark or microscope zoom level not appropriate during surgery. In such an event the surgeon would not be able to accurately see to align the lens. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2016-00014 |
| MDR Report Key | 5537484 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-03-31 |
| Date of Report | 2016-06-23 |
| Date Mfgr Received | 2016-05-30 |
| Date Added to Maude | 2016-03-31 |
| 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 | 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 | 2016-03-31 |
| Model Number | X-SPM |
| Catalog Number | 8065998243 |
| Lot Number | ASKU |
| ID Number | ASKU |
| 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 | 2016-03-31 |