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

Catalog Number	8065990794
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
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 during the treatment in the left eye of a patient, the system flap has started to come into range while the treatment was firing.The lights needed to be turned down to expand a small pupil, the doctor could not see the flap going onto the ablation area alerted and pulled the flap back accordingly but some of the treatment appeared to be blocked by the flap prior resulting in an incomplete corneal ablation during lasik surgery.The patient is experiencing good visual outcomes in that left eye.Right was unaffected and treated with no issues.
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 initially installed at the customers was then moved and afterwards successfully verified per service and installation record.A clinical application specialist reported that turing the treatment of the patients left eye on a device his flap started to come into range while the treatment was firing.Per the initial report, the patient is nevertheless doing well visually in that eye.Based on the assessment of the clinical information and the provided report description, it was found that the reported issue was not related to the device.Instead, it was caused by the flap folding over onto the ablation zone during the treatment.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: 23095165
• Report Number: 3003288808-2025-00372
• Device Sequence Number: 9226250
• Product Code: LZS
• UDI-Device Identifier: 00380659907944
• UDI-Public: (01)00380659907944(17)441125(11)241125(10)175NAM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: 175NAM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Patient Age: 34 YR
• Patient Sex: Male