MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2015-06-12 for VERION DIGITAL MARKER M X-SPM 8065998244 manufactured by Wavelight Gmbh (agps).
[5939732]
A surgeon reported a case of incorrect intraocular lens (iol) axis alignment of the right eye, observed at one week post operative visit. Reporter indicated the patient was returned to the operating room, and the iol was rotated into the correct axis of alignment. Upon additional follow up, the reporter relayed the doctors seating position was not selected correctly to fully align with the correct axis position of the iol.
Patient Sequence No: 1, Text Type: D, B5
[13365225]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24684807]
Root cause: technical root cause a defective data communication cable was identified. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24684808]
Upon further follow up, the reporter indicated the reported problem was due to a data communication cable connecting the digital marker to the video overlay.
Patient Sequence No: 1, Text Type: D, B5
[26046216]
The reported communication cable was determined to be unrelated to the event of misalignment of the intraocular lens (iol) rotation. Upon additional review, the root cause could be identified as a user failure to identify the doctor position selection, which lead to wrong alignment of the iol. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010300699-2015-00503 |
| MDR Report Key | 4841970 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2015-06-12 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-08-07 |
| Device Manufacturer Date | 2014-11-06 |
| Date Added to Maude | 2015-06-12 |
| 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 | TELOW BERLIN 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 | 2015-06-12 |
| Model Number | X-SPM |
| Catalog Number | 8065998244 |
| Lot Number | ASKU |
| ID Number | 2.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAVELIGHT GMBH (AGPS) |
| Manufacturer Address | RHEINSTRASSE 8 TELOW BERLIN 14513 GM 14513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-06-12 |