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

Model Number	X-SPM-03
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported a situation where the guidance system showed incorrect indications during surgery.The surgery had to proceed with manual marking due to this issue.Unfortunately, lack specific information regarding the affected eye and the patient's identifier.During the initial surgery on (b)(6) 2023, a toric intraocular lens was implanted based on the system, but it did not effectively correct the astigmatism.The patient experienced difficulty with their vision as a result.Therefore, on (b)(6) 2023, the surgical team reoriented the axis of the lens.During this reorientation, it was observed that the intraocular lens itself was not off-axis, and the system display indicated the same location as before.However, when manual marking was performed, disregarding the system, a misalignment of approximately twenty degrees was noted.Following the surgery, the patient's vision significantly improved, and no further complaints were reported.
Additional Manufacturer Narrative
H.3., 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).
Additional Manufacturer Narrative
A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Based on the data provided, the product subject matter expert found that using the same settings as the surgeon, a valid registration was not possible.The system does propose a registration, however the proposed registration is not good as there are no matching scleral vessels between the diagnostic and intra-operative image.By switch the microscope orientation to forty five degree (oblique) and re-attempt registration, a reliable registration with proper scleral vessel matching can be achieved.Therefore, the investigation is concluded.Incorrect microscope orientation selection following which an incorrect registration proposal was confirmed by the surgeon.This led to the mis-display of the axis at the digital marker.Therefore, the root cause code user handling.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: 17886848
• Report Number: 3010300699-2023-00009
• Device Sequence Number: 17891134
• Product Code: HLG
• UDI-Device Identifier: 00380659982705
• UDI-Public: 00380659982705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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): Initial
• Initial Date Received by Manufacturer: 09/17/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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 Age: 66 YR
• Patient Sex: Female