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	01/02/2026
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 due to the patient's thin cornea, the flap thickness was not adjusted, and the treatment proceeded.However, during the procedure, the tunnel laser again struck the patient interface, and the bed cut demonstrated characteristics of a thin flap.Despite replacing the patient interface a z axis error persisted, leading the physician to halt the treatment.The next treatment plan was to be reconsidered following the patient¿s corneal recovery in the right eye during refractive surgery.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.11.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.Most recent onsite visit from field service engineer.Field service engineer performed and signed service installation record.System meets specifications as per service installation record.Due to a recent increase in "corneal flap complication-thin" and "corneal flap complication-incomplete" cases a non-conformance investigation was opened to investigate on potential contributing factors and similarities between the increased amount of new cases.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.Directly before the reported treatment the treatment was already planned once, but was canceled during planning with the error message.The beam control check of the reported treatment resulted in a correction of sixty five microns.The treatment of the patient´s right eye was interrupted three times, by the customer releasing the laser pedal and finally aborted by the user during bed cut.Treatment was only fifty nine percent complete.The laser showed the info message: ¿vacuum pumps stopped by foot pedal - treatment is aborted¿.No relevant deviation between planned and performed energy is detectable for the reported treatment.The user operated within the recommended energy settings.The thickness of the flap was thinner than the recommended flap thickness.The user restarted the treatment on the same day.The beam control check for the re-treatment resulted in a correction of thirty nine microns.Also the re-treatment was interrupted twice, by the customer releasing the laser pedal and also aborted by the user during bed cut.Treatment was only sixty four percent complete.The laser showed the info message: ¿vacuum pumps stopped by foot pedal - treatment is aborted¿.No relevant deviation between planned and performed energy is detectable for the reported treatment.The thickness of the flap was set to one hundred ten microns during the re-treatment.Together with the error messages directly prior to the reported treatment the logfiles show the error message.Review of the log files for the treatment day does not show any other relevant warning or error messages.The root cause could not be identified during logfile review.During an onsite visit by the local field service engineer the application interface, beam expander and z-scanner were exchanged.The exchange was preventively done as no clear defect could be identified to the exchanged parts.The three replaced parts were damaged by the field service engineer to prevent to be used by others and are therefore not expected to return for investigation.No device malfunction could be confirmed during investigation.Therefore, the case is coded as "inconclusive - product met specifications".Most likely cause for the reported event is a patient interface that was inserted bend into the device.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: 24219526
• Report Number: 3003288808-2026-00076
• Device Sequence Number: 9366360
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)410803(11)210803(10)1417X3
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: 1417X3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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
• Patient Age: 16 YR
• Patient Sex: Female