MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number	8065990794
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/05/2025
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 patient visual acuity was stable and clear but the patient has experienced longstanding floaters and flashes in periphery in the left eye after refractive surgery along with application of medication.Patient reports has not been using lid scrubs.There are two related reports for this patient.This report addresses the patient's left 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.A review of the technical service onsite showed no abnormalities that could have contributed to this event.Within the preventive maintenance program, the device was regularly serviced and was successfully verified prior to and after the surgery date.Most recent technical site visit confirmed device met specifications as per service and installation record.Logfile review for the day of treatment shows all laser system functions were within specifications for the respective treatment.The system passed successfully all initialization steps.The logfile shows nine successfully performed treatments.The logfile shows that the reported treatment of left eye was performed successfully without interruptions.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 product or component is expected to return for investigation the events recorded for this complaint are unrelated to the performed surgery as they were reported prior to its execution.It is therefore unclear, what specific issue was alleged.However, no technical issue could be identified as the product was found to be within specifications.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Common Device Name: OPHTHALMIC EXCIMER LASER SYSTEM
• 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: 23896151
• Report Number: 3003288808-2025-00615
• Device Sequence Number: 17277893
• Product Code: LZS
• UDI-Device Identifier: 00380659907944
• UDI-Public: (01)00380659907944(17)420117(11)220117(10)1470Y6
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 8065990794
• Device Lot Number: 1470Y6
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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 Age: 26 YR
• Patient Sex: Male