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 2017-03-21 for VERION DIGITAL MARKER L X-SPL 8065998241 manufactured by Wavelight Gmbh (agps).
[70421294]
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
[70421295]
A surgeon reported a case of oblique astigmatism post cataract procedure. The reporter indicated the image guided system recommended axial placement was off alignment and did not correct the cylinder power. Reporter indicated the intraocular lens (iol) was rotated three days later, and patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
[86891334]
No technical root cause could be determined. A potential contributing factor could be related to an incorrect selection of doctor seating position may result in a wrong displayed axis shown in the overlay and could lead to the reported problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00004 |
| MDR Report Key | 6420252 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-21 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-05-24 |
| Date Added to Maude | 2017-03-21 |
| 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 | MS. RITA LOPEZ |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8175514846 |
| Manufacturer G1 | WAVELIGHT GMBH (AGPS) |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW 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 L |
| Generic Name | MARKER, OCULAR |
| Product Code | FTH |
| Date Received | 2017-03-21 |
| Model Number | X-SPL |
| Catalog Number | 8065998241 |
| Lot 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 | 2017-03-21 |