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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2023
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
A healthcare professional reported that an intraocular lens was found placed in the wrong axis in an unidentified eye after surgery.The intraocular lens was re-rotated.Patient symptoms were continuing.There are two related reports for this event.This report addresses patient initials (b)(6) unknown eye and other manufacturer reports will be filed.
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.Per the manufacturer's subject matter expert, the case could not be investigated completely, as the lens position at the end of the first surgery was at the intended location by the surgeon.The data from the second surgery would be required to identify the lens position and to visually verify how far was the misalignment.This data could not be gathered, hence the investigation is concluded without identifying a root cause and will be restarted if the requested data was provided.The provided information was insufficient to properly conduct the investigation and the required data could not be obtained.Therefore, the event could not be confirmed and the root cause could not be identified.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: 18443247
• Report Number: 3010300699-2024-00002
• Device Sequence Number: 15174436
• Product Code: HLG
• UDI-Device Identifier: 00380659982705
• UDI-Public: 00380659982705
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: X-SPM-03
• Device Catalogue Number: 8065998270
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• 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: Male