MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[69257587]
Additional information has been requested. 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69257588]
A surgeon reported a variation of almost 45 degrees between two recognitions for implantable contact lens (icl) prior to image guided cataract surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[76650314]
No technical root cause could be determined based on the information that was provided. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00003 |
| MDR Report Key | 6374890 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-05-23 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-03-02 |
| 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 |
| 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 | 2017-03-02 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | 00380659982446 |
| 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 | 2017-03-02 |