MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-23 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[65911339]
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
[65911340]
A doctor reported toric axis tab switched over to left eye when performing a cataract procedure on a patient's right eye. Incision and capsulorhexis tab were used for right eye successfully prior. The surgeon did not notice the incorrect axis at first. It was not until the nurse went to the finalization screen and was confirming the information that left eye was noticed. Intraocular power was also incorrect for the right eye since it was showing that the left eye was being performed. The doctor went back to the axis screen and double checked and it was incorrect. The surgeon then rotated the intraocular lens into the correct position per his medical chart.
Patient Sequence No: 1, Text Type: D, B5
[74539697]
The device history record was reviewed. No abnormalities that could have contributed to this event were found and the product was released according to company acceptance criteria. On the basis of the data received, it could comprehended an operator error. It cannot exactly be determined how or when the fault occurred but due to this information, the system had loaded the data correctly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00001 |
| MDR Report Key | 6271384 |
| Date Received | 2017-01-23 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2014-07-15 |
| Date Added to Maude | 2017-01-23 |
| 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 | 2017-01-23 |
| 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 | 2017-01-23 |