MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	8065990941
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
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 physician reported that during the procedure a very sticky flap was created that was very difficult to lift the flap with central adhesions on the patient's right eye during refractive surgery.The patients left eye flap was easy to lift with no issues.The procedure was completed on same day.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.11.A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the technical service onsite history showed no abnormalities that could have contributed to this event.The device was successfully verified prior and after the day of event.Most recent onsite visit from field service engineer was performed and signed service installation record.System meets specifications as per service installation record.The review of logfile for the day of treatment shows all laser system functions were within specifications.The reported treatment could be identified in the logfile.The logfile shows that the beam control check was performed before the start of the treatment and not immediately before the treatment.The surgeon missed vacuum two once during the docking process/before the treatment.Patient interface cone was docked twice on patient¿s eye because the surgeon has had difficulties to reach a valid suction two value.The logfile shows vacuuming one time and vacuum two time the duration of the docking process.The treatment of the patient's right eye was finished successfully.The thickness of the flap was thinner than the recommended flap thickness.No technical root cause could be identified during logfile review.The system was working within specification.No part is expected to be returned to device for evaluation.No on-site visit by a field service engineer was identified in relation to the reported issue.No root cause for the reported event could be determined, as the device was found to meet specifications.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24242866
• Report Number: 3003288808-2026-00081
• Device Sequence Number: 8309886
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)431006(11)231006(10)168CNU
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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 Catalogue Number: 8065990941
• Device Lot Number: 168CNU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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: 33 YR
• Patient Sex: Male