MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M; MARKER, OCULAR

Model Number	X-SPM-03
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.: 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 manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that, during an unspecified surgical procedure, the system displayed an incorrect axis in an unidentified eye at an unknown timing.
Additional Manufacturer Narrative
All product and batch history records are quality reviewed prior to product release.Further information about the reported issue was requested but not provided.No sample was expected to be returned for evaluation and not enough information was provided to perform an investigation.This case is therefore closed without identifying a root cause.Not enough information was provided to properly complete an investigation.The root cause could not be identified by the investigation.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.11.All product and batch history records are quality reviewed prior to product release.Further information about the reported issue was requested but not provided.No sample was expected to be returned for evaluation and not enough information was provided to perform an investigation.This case is therefore closed without identifying a root cause.Upon request, the data collection for this case was performed and provided to the manufacturer's product subject matter expert (sme), who found that six cases were associated with this report.For five of the occurrences, the planned lens position was changed by the surgeon on the digital marker microscope.The concrete situation making this change necessary could not be reconstructed by the investigation but no issue and therefore no root cause could be identified.For the sixth case, an incorrect microscope orientation was selected by the surgeon, which lead to an invalid registration and therefore a wrong axis display.It was also found that for several cases, the eye was de-centered, which was indicated by verion.It is recommended to always follow the status messages to ensure a reliable tracking performance during surgery.For none of the cases, there was any information regarding a follow-up surgery, indication that there was no deviation of the lens position.This investigation is concluded based on the provided data.For all of the cases, the device behaved as intended.For one of the case, the wrong axis was displayed due to a wrong user selection.Therefore, the root cause code "external - user handling" was selected.The manufacturer internal reference number is: (b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Common Device Name: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18071241
• Report Number: 3010300699-2023-00014
• Device Sequence Number: 7615559
• Product Code: HLG
• UDI-Device Identifier: 00380659982705
• UDI-Public: 00380659982705
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X-SPM-03
• Device Catalogue Number: 8065998270
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 08/20/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 03/28/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown