MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-10 for VERION DIGITAL MARKER M X-SPM 8065998243 manufactured by Wavelight Gmbh (agps).
[74889370]
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
[74889371]
A doctor reported incorrect intraocular lens (iol) placement post image guided cataract procedure. Reporter indicated the patient had to undergo a secondary surgical procedure to reposition the iol by 90 degrees.
Patient Sequence No: 1, Text Type: D, B5
[78987311]
Attempts were made to obtain additional information; however, no information has been received. An intraocular lens (iol) wrongly implanted by 90 degrees could likely be a result of a wrong selected doctor position since this matches the scaling of selecting the doctor position. 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. Furthermore, the user is required to verify that the reference image does match with the patient's real image by comparing the vessel structures in the blending screen. Most likely the root cause is use error, but could not be determined conclusively. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[78987312]
Attempts were made to obtain additional information; however, no information has been received.
Patient Sequence No: 1, Text Type: D, B5
[80445981]
Event occurred (b)(6) 2017 and not (b)(6) 2017 as originally reported. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2017-00008 |
| MDR Report Key | 6559127 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-10 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-05-10 |
| 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 |
| Remedial Action | OT |
| 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 | 2017-05-10 |
| Model Number | X-SPM |
| Catalog Number | 8065998243 |
| Lot Number | ASKU |
| ID Number | NA |
| 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. Required No Informationntervention | 2017-05-10 |