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 Codes	Conjunctivitis (1784); Corneal Edema (1791)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The event report for this file was received from the chinese health authority.A non-healthcare professional reported that the corneal flaps were created in both eyes.The planned flap thickness was one hundred ten microns however, midway through the system scan, it was found to be an epithelial flap.The flap was repositioned with a different patient interface, but the same issue occurred midway through the system scan and the procedure was terminated.The surgery was rescheduled.The bandage contact lens was placed.On further examination, it was noted that conjunctival congestion and mild corneal epithelial edema, no other obvious abnormalities observed in right eye of the patient.The fellow eye was clear and no other obvious abnormalities observed.
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
The event report for this file was received from (b)(6).A non-healthcare professional reported that the corneal flaps were created in both eyes.The planned flap thickness was one hundred ten microns however, midway through the system scan, it was found to be an epithelial flap.The flap was repositioned with a different patient interface, but the same issue occurred midway through the system scan and the procedure was terminated.The surgery was rescheduled.The bandage contact lens was placed.On further examination, it was noted that conjunctival congestion and mild corneal epithelial edema, no other obvious abnormalities observed in right eye of the patient.The fellow eye was clear and no other obvious abnormalities observed.New information was received via follow-up from company representative that the same complaint details were captured in the file id (b)(4).Hence this file id (b)(4) to be cancelled and all the information and documents will be moved to the file id (b)(4).
Additional Manufacturer Narrative
Additional information provided in b.5., h.2., h.11., this is a duplicate of manufacturer report number 3003288808-2026-00093.No additional reports will be filed on this report number 3003288808-2026-00093.Any additional information that is received will be reported in manufacturer report number 3003288808-2026-00076.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: 24334015
• Report Number: 3003288808-2026-00093
• Device Sequence Number: 11990662
• Product Code: GEX
• UDI-Device Identifier: 00380659909412
• UDI-Public: (01)00380659909412(17)410803(11)210803(10)1417X3
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 1417X3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 08/03/2021
• 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; Required Intervention
• Patient Sex: Unknown