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)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
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
A healthcare professional reported that the toric overlay displayed incorrect axis alignment and was rotated by ninety degrees from its original position during a cataract procedure in an unspecified eye.
Additional Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.During the evaluation it was found that the digital marker microscope behaved as intended and there is no product malfunction.A local clinical application specialist interviewed the customer and found out that the surgeon operates from a superior position for the right eye and operates from a temporal position for the left eye.This is why the surgeon most likely selected a microscope orientation that did not represent correctly where the surgeon is located relative to the patient.This caused a ninety degree flip in the toric axis alignment.Based on this information, the clinical application specialist has been in touch with the customer to resolve the situation.This issue is therefore related to user handling of the product.The root cause is user handling, the device meets its specifications.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: 17833132
• Report Number: 3010300699-2023-00008
• Device Sequence Number: 3390058
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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