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	01/15/2026
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 non-healthcare professional reported that the small segment of side cut was incomplete in right eye because of limited applanation due to the patient's anatomy with very small corneal diameter.The surgeon was able to get the majority of the flap up without the use of additional instruments and proceeded with treatment.The procedure was completed and no medical intervention required.
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 was the installation of the device 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 energy was stable during the whole day.The reported treatment could be identified in the logfile.The logfile shows vacuum one time was around ninety five mins., the vacuum two time was around forty seven sec., the duration of the docking process was around one twenty seven mins., and the total treatment duration was around one forty two mins.The surgeon lost vacuum one one times and vacuum two twice during the docking process or before the treatment.Suction ring and patient interface were docked three times on patient¿s eye because the surgeon has had difficulties to reach a valid suction one and two value.The treatment of the patient's right eye was finished successfully.Review of the logfiles for the treatment day shows no relevant warning or error messages.No technical root cause could be identified.The system was working within specification.No complaint-related product is expected to return for investigation.No associated service visit for the reported event could be identified.Root cause could be determined as external, patient condition related (small corneal diameter).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: 24269292
• Report Number: 3003288808-2026-00083
• Device Sequence Number: 10726685
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)450409(11)250409(10)17CHPK
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 17CHPK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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: 35 YR
• Patient Sex: Male