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	Corneal Abrasion (1789)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
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 flap edge could not be separated, resulting in corneal epithelial damage in the right eye of a patient, during refractive surgery.The surgery was completed on same day.There are two related reports for this patient.This report addresses the patient's right eye and another manufacturer report will be filed for the fellow eye.
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.Most recent onsite visit from field service engineer was the installation of the device.Field service engineer 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 this period.The reported treatment could be identified in the logfile.The beam control-check resulted in a correction of thirty-four microns.The treatment of the patient's right eye was finished successfully without any issue.No 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.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.After the reported case the device was investigated by the local field service engineer, together with the help of global technical service.During the investigation no technical issue was identified that could have led to the reported event.The device was working within specifications.No complaint-related product is expected to be returned for investigation.No device related issues were identified based on the provided data.Therefore, the case is coded as "inconclusive - device met specifications".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: 24064516
• Report Number: 3003288808-2026-00053
• Device Sequence Number: 16019130
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)450908(11)250908(10)17MUMD
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065990941
• Device Lot Number: 17MUMD
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Male