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 2017-07-31 for VERION DIGITAL MARKER M X-SPM 8065998242 manufactured by Wavelight Gmbh (agps).
[81367649]
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
[81367650]
A doctor reported that a green flash from the optic of the microscope dazzled his eyes. The surgeon was performing a toric intraocular lens implant procedure when this occurred. During the surgery, the imaging system bugged. The green flash dazzled the surgeon. The surgeon shouted and experienced discomfort and a white veil appeared in front of his eyes. The incident lasted about 30 seconds. The surgeon was about to finish the surgery he was performing. Surgeon is concerned about potential sequela following the flash. Upon follow up, glare was reported to have lasted about four minutes. Surgeon was afraid of losing part of his vision. There are two related reports for this patient. This report addresses the patient's right eye and another manufacturer report will be filed for the fellow eye.
Patient Sequence No: 1, Text Type: D, B5
[113538392]
No anomalies found by review of device history record. Product met all specifications when released. At the visit on site, the field service engineer could not reproduce the error. Fse tried by himself during testing and confirms that the microscope integrated display (mid) behaves just like any other mid. Little green light at start up but nothing very intensive. Tuning control/check: test in accordance with the procedure. Control according to procedure-device in keeping with the company specifications. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00021 |
| MDR Report Key | 6753297 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-31 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-08-23 |
| Date Added to Maude | 2017-07-31 |
| 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. NADIA BAILEY |
| Manufacturer Street | RHEINSTRASSE 8 |
| Manufacturer City | TELTOW D-14513 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-14513 |
| Manufacturer Phone | 8176152230 |
| 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 | 2017-07-31 |
| Model Number | X-SPM |
| Catalog Number | 8065998242 |
| Lot Number | ASKU |
| ID Number | 00380659982422 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-31 |