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

Model Number	X-SPL-03
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2023
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 capsulotomy center position was placed well below the iris center and iris repositioning manually brought to the center of the pupil and was placed there in the unknown eye of a patient, during cataract surgery.After manually repositioning, the surgery was completed without problems.The patient identifier is not available.There's no patient harm.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.10.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.During investigation it was determined that is the background illumination to be the issue.The reported issue is related to the background illumination.Root cause could be identified as a user error.The manufacturer internal reference number is: (b) (4).

• Brand Name: VERION DIGITAL MARKER L
• 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: 17340637
• Report Number: 3010300699-2023-00004
• Device Sequence Number: 6912563
• Product Code: HLG
• UDI-Device Identifier: 00380659982699
• UDI-Public: 00380659982699
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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-SPL-03
• Device Catalogue Number: 8065998269
• 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: 07/02/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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