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	12/11/2025
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 health care professional reported actual flap was thinner than the planned flap thickness in unknown eye of the patient during refractive surgery.Additional information was requested.
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 review 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 performed and signed service installation record.The device meets specification as per service installation record.The review of logfile for the day of treatment shows all laser system functions were within specifications.The vacuum check, the energy check and the ablation check were performed successfully without issues.The energy was stable during the whole day.The logfile shows thirty eight successfully performed treatments without interruptions.Due to missing information about the treatment details the related treatment cannot be identified in the logfile.The review of the complete treatment day shows that fifteen beam control checks were performed way before the start of the treatments and not immediately before the treatments.The beam control check correction factors vary strongly through the day of treatment with the lowest correction factor being minus nineteen microns and the highest plus sixty eight microns.The review also shows that during all treatments the suction process was achieved without missed vacuum one or two and re-dockings.The review also shows that all treatments were performed with no or not relevant deviation between planned and performed energy.Throughout the logfiles the error message of error during focus control was shown a total of nine times and the error message of focus control was shown twice.Review of the log files for the treatment day does not show any other relevant warning or error messages.No technical root cause could be identified.The system was working within specification.During an onsite visit by the local field service engineer, the z-scanner was replaced, because of intermittent thin flaps, however within the service record it is stated that the event was neither confirmed nor replicated.Further information and the exchanged scanner were requested but not yet received.No device related issues were identified based on the provided data.The investigation showed several handling related factors, that may contribute to an outcome similar to the reported event.Therefore, the case is coded as "inconclusive - other".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: 24487316
• Report Number: 3003288808-2026-00124
• Device Sequence Number: 5092331
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 13XU4R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
• Patient Sex: Unknown