MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	8065990941
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Keratitis (1944)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that patient had experienced diffuse lamellar keratitis in the left eye, after refractive surgery, and had a potential quality issue with the patient interface original batch.The patient¿s symptoms resolved.The hospital confirmed that there have been no recent changes in postoperative medication practices, and no changes to surgical instruments.Relevant investigations are currently ongoing to determine the root cause.There are multiple related reports for this facility.This report addresses the patient initial (b)(6) in the left eye and other manufacturer reports will be filed.
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).
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.A review of the technical service onsite history 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.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 vacuum check, the energy check and the ablation check were performed successfully without issues.The energy was stable during the whole day.The reported treatment could be identified in the logfile.The surgeon lost vacuum one time and vacuum two once during the docking process/before the treatment.Suction ring and patient interface were docked twice 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 left eye was finished successfully without any issue.Review of the logfiles for the treatment day shows no 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.No device related issues were identified based on the provided data.Therefore, the case is coded as "inconclusive - no problem found".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: 24739272
• Report Number: 3003288808-2026-00179
• Device Sequence Number: 9790756
• Product Code: GEX
• 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
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 02/27/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Male