MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-11-10 for VERION DIGITAL MARKER M FOR LEICA MICROSCOPES X-SPM 8065998242 manufactured by Wavelight Gmbh (agps).
[15114358]
A surgeon reported that during intraocular lens (iol) alignment to the vertical axis, the digital marker indicated a second vertical axis at 20-30 degrees. This event was reported to have been observed twice. No pt harm was reported. Add'l info has been requested, but not received to date.
Patient Sequence No: 1, Text Type: D, B5
[15471026]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with cfr 803. 56 when add'l reportable info becomes available. Add'l info has been requested but not received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2014-00008 |
| MDR Report Key | 4280320 |
| Report Source | 01,05,07 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-10-17 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2014-12-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-14 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERION DIGITAL MARKER M FOR LEICA MICROSCOPES |
| Generic Name | CAMERA, STILL, MICROSURGICAL |
| Product Code | FTH |
| Date Received | 2014-11-10 |
| Model Number | X-SPM |
| Catalog Number | 8065998242 |
| Lot Number | NA |
| 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 | AM WOLFSMANTEL 5 ERLANGEN 91058 GM 91058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |