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	02/04/2026
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 healthcare professional reported that the actual flap was fifteen microns thinner than the planned flap thickness in unknown eye of the patient during refractive surgery.There are multiple related reports for this facility.This report addresses for unknown patient, unknown eye and other manufacturer reports will be filed.
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 was performed and signed service installation record.The device meets specification as per signed service installation record.The device was successfully verified prior and after the day of event.Further data for the reported event were requested but not received.No complaint-related product is expected to return for investigation.No associated service visit for the reported event could be identified.Not enough information was provided to properly complete an investigation.Therefore, the root cause of the reported event could not be identified.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: 24493767
• Report Number: 3003288808-2026-00125
• Device Sequence Number: 10638644
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)450205(11)250205(10)178CCW
• 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): 06/10/2026

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: 178CCW
• 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: 05/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
• Patient Sex: Unknown