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

Model Number	X-SPM-03
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
The customer reported using the system surgery plan in the theater, but an incorrect patient was loaded into the system in the unknown eye during surgery.The marker was successfully registered, and the surgery was completed.The patient reported a problem with the team time out, as the patient was also implanted with the incorrect lens, which has since been explanted and replaced.The clinical application team will follow up with the complainant and the facility.The medical intervention was performed and the replacement of the incorrectly implanted has been completed.
Additional Manufacturer Narrative
A manufacturing device history record review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.During the evaluation it was found that the system behaved as intended.The issue is related to user handling of the product and the incident was outlined as follows: the surgical order was changed on the day and the incorrect notes supplied to theatre with the incorrect patient.This was not picked up during the "time-out", so the surgery proceeded with the incorrect intra-operative lens being implanted and the incorrect system surgical plan loaded and executed.The registration was accepted on the system at the time by the surgeon.This error was subsequently picked up when a patient of the same name and intra ocular lens power later presented for surgery on the same day.The investigation is completed.The user accidentally selected the wrong patient plan as both patient name was the same due to human error.Therefore, this case is unrelated to the device (system met specifications) and the root cause is 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: 18071185
• Report Number: 3010300699-2023-00013
• Device Sequence Number: 12660930
• Product Code: HLG
• UDI-Device Identifier: 00380659982705
• UDI-Public: 00380659982705
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: X-SPM-03
• Device Catalogue Number: 8065998270
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown