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	01/10/2026
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 nurse reported that the patient experienced diffuse lamellar keratitis in the right eye after refractive surgery.The hospital confirmed that there were no changes in postoperative medication regimens, and no changes were made to surgical instruments during this timeframe.The hospital was unable to identify a definitive root cause and raised concerns regarding potential instability of the system laser energy or possible quality issues related to the patient interface.There are multiple related reports for this event.This report addresses the unknown patient initial's, (b)(6) the right eye and other manufacturer reports will be filed.
Event or Problem Description
A nurse reported that the patient experienced diffuse lamellar keratitis in the right eye after refractive surgery.The hospital confirmed that there were no changes in postoperative medication regimens, and no changes were made to surgical instruments during this timeframe.The hospital was unable to identify a definitive root cause and raised concerns regarding potential instability of the system laser energy or possible quality issues related to the patient interface.There are multiple related reports for this event.This report addresses the patient initial's (b)(6), in the right eye and other manufacturer reports will be filed.
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3.A., 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 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 was performed and signed service installation record.The device 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 energy was stable during the whole day.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.While the root cause and its origin are inconclusive, the following factors could potentially contribute to an outcome similar to the reported event: typically, diffuse lamellar keratitis is not directly attributable to the device.Contributing factors of diffuse lamellar keratitis could be sterilization of instruments, environment of the facility, surgical techniques as well as pre and post-operative medications.No complaint-related product is expected to return for investigation.No device related issues were identified based on the provided data.Therefore, the case is coded as "inconclusive - product 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: 24361720
• Report Number: 3003288808-2026-00098
• Device Sequence Number: 5066412
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)440301(11)240301(10)16KV2V
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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
• Device Lot Number: 16KV2V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Female