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).
[69260676]
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
[69260677]
A surgeon reported, a 30-40 degrees difference between two recognitions for implantable contact lens prior to image guided cataract surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[73476834]
System data received and analyzed. The root cause was identified as user error. System data provides evidence that the surgeon has selected a doctor position of -90 degrees instead of +90 degrees. The device in this case is not able to register the diagnostic image to the patient's image which resulted in a wrong registration angle. The surgeon did not further not review the provided registration angle which confirmed wrong astigmatism axis, and resulted in an incorrect implanted intraocular lens (iol. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73476835]
Additional information received, a restart of the machine resolved the issue and there were no consequences to patients.
Patient Sequence No: 1, Text Type: D, B5
[74609302]
The user recognized this issue when checking the proposed registration according to user instruction. There was no impact to the patient. The root cause was a general lack of understanding the device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00002 |
| MDR Report Key | 6374889 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-04-10 |
| 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 | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| 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 | 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 | RHEINSTRASSE 8 TELTOW 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-02 |