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	01/29/2026
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 flap was sticky and incomplete flap was centrally cut in the right eye of a patient during refractive surgery.
Additional Manufacturer Narrative
Additional information provided in b.5., 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.A review of the technical service onsite 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 signed service installation record.After the event the system was inspected by the local field service engineer.No issues were discovered during the inspection and all values were within specification.Field service engineer performed and signed service installation record.System 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 reported treatment could be identified in the logfile.The treatment of the patient's right eye was finished successfully without any issue.No relevant deviation between planned and performed energy is detectable for the reported treatment.The user operated within the recommended energy settings.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.Root cause could be determined as external, patient condition related (patient moved).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that the surgeon tried to lift the flap, but it was sticky and unable to lift the flap which resulted in an incomplete flap in the right eye of the patient during refractive surgery.The procedure was aborted in the right eye of the patient.Additionally no suction loss and medical intervention reported.

• 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: 24452414
• Report Number: 3003288808-2026-00109
• Device Sequence Number: 13088922
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)440503(11)240503(10)16T27A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/25/2026

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: 16T27A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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: 38 YR
• Patient Sex: Female