MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[42411991]
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 device history records (dhr) for the device was reviewed. The associated device was released based on company acceptance criteria. No anomalies found by review of device history record. Product met all specifications when released. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42411992]
A doctor reported a toric intraocular lens was implanted wrongly about 22 while using digital marker device. Lens was twisted 22. 5 clockwise. The preset of the sitting position as not been completely temporal (22. 5) 79 was planned and ended up with 57. Revision was performed and 86 as the outcome. Upon follow up, there was not a wrong sitting position applied by the user.
Patient Sequence No: 1, Text Type: D, B5
[47251328]
No anomalies found by review of device history record, product met all specifications when released. Product was not returned for investigation. Data was provided, however, the related surgery could not be identified in the data. The reported issue might not have been performed with the device reported. A wrong implanted iol can have several causes. If the doctor selects the wrong doctor position, the device will not be able to register the correct angle. Poor illumination can also be a reason for not properly registering. In both cases, the surgeon must confirm that the registration of the image has been established successfully to proceed with the workflow. All described possibilities are a result of improper handling of the device. If more data becomes available for further investigation, information will be updated accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47251329]
A necessary correction was identified regarding incident description narrative previously provided. The statement "upon follow up, there was not a wrong sitting position applied by the user" was a comment from a company representative and not a verified fact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010300699-2016-00016 |
| MDR Report Key | 5568886 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-06-09 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2016-05-19 |
| Device Manufacturer Date | 2015-09-28 |
| Date Added to Maude | 2016-04-11 |
| 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 | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | AM WOLFSMANTEL 5 |
| Manufacturer City | ERLANGEN 91058 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91058 |
| Manufacturer Phone | 8175686660 |
| 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 | 2016-04-11 |
| 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; 2. Required No Informationntervention | 2016-04-11 |