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	12/26/2025
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 non-healthcare professional reported during the flap creation the patient moved or squeezed the eye due to this the flap wouldn't come up resulted in incomplete flap.The flap was recut and created a new flap in the left eye of the patient during refractive surgery.The flap came with no issues.The procedure was completed and no medical intervention required.
Additional Manufacturer Narrative
Additional information provided in d.4., 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 the day of event.Most recent onsite visit from field service engineer performed and signed service installation record.System meets specification as per service installation record.No on-site visit by a field service engineer was identified in relation to the reported issue.The review of logfile for the day of treatment shows all laser system functions were within specifications.The patient's left eye was treated twice on the reported event date.Both treatments could be identified in the logfile.The surgeon interrupted the initial treatment twice by releasing the laser pedal during side cut.The reason why the user interrupted the treatment is not visible in the logfile.The treatment of the patient's left eye was finished.The user restarted the treatment on the same day.The corresponding treatment of the patient's left eye was finished successfully.No technical root cause could be identified during logfile review.The system was working within specification.No part is expected to be returned to manufacturer for evaluation.No technical root cause was identified as the product was found to be within specifications.The root cause is patient condition related.The patient's nervousness could have been a contributing factor.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: 24128781
• Report Number: 3003288808-2026-00071
• Device Sequence Number: 17494592
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)421020(11)221020(10)154D4N
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 154D4N
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: 21 YR
• Patient Sex: Male