MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-08-01 for VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[4877223]
An ophthalmic surgeon reported that after cataract surgery she identified a deviation in the axis for the implanted toric iol in three patients. During surgery, she saw a rotation of the final axis compared with the initially planned axis. This led to residual astigmatism that was corrected with eye glasses. For this pt surgeon reported a jump on the marks for the incision of 30 degrees. The surgeon indicated the postoperative astigmatism was due to the system makings and not due to a postoperative iol rotation. Additional info was received from the surgeon. During surgery, markings in the microscope and in the display were permanently changing, thus making it difficult to guess which was the correct toric alignment axis. The surgeon chose one of the multiple axis displayed and postoperatively the iol presented a rotation of 12 degrees deviation from the preoperatory axis suggested by the digital marker (164 degree instead of 176 degree). The rotation was observed on the first postoperative day and persisted one month after surgery. The pt was not willing to undergo iol repositioning. Additional info has been requested but not received to date.
Patient Sequence No: 1, Text Type: D, B5
[11950073]
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 info becomes available. Additional info has been requested but not received to date. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2014-00002 |
| MDR Report Key | 4024527 |
| Report Source | 01,05 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-04 |
| Date of Event | 2014-06-04 |
| Date Mfgr Received | 2014-07-04 |
| Date Added to Maude | 2014-08-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY R3-48 |
| 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 ZEISS MICROSCOPES |
| Generic Name | CAMERA, STILL, MICROSURGICAL |
| Product Code | FTH |
| Date Received | 2014-08-01 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | NA |
| ID Number | UNK |
| 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 | 1. Required No Informationntervention | 2014-08-01 |