MAUDE Adverse Event Report: Carl Zeiss Meditec AG (Jena) MEL 90; Excimer Laser System,

Catalog Number	000000-2179-684
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine maintenance inspection, a zeiss engineer detected an irritating odor and confirmed a leakage of the mixed fluorine argon gas (arf gas) which is necessary to use the excimer laser of mel 90 device.The zeiss engineer detected abnormal gas consumption and identified the main valve premix valve mv-arf to be defective and causing a gas leakage.The zeiss engineer corrected the issue during the maintenance of the device.After replacing the premix arf valve, the equipment returned to normal.Based on the available information, no negative impact, e.G.Injury, nausea, feeling unwell or nose bleeding, was reported for any patient, user, third party, or the zeiss engineer involved in the service activity.

• Brand Name: MEL 90
• Common Device Name: Excimer Laser System,
• Manufacturer (Section D): Carl Zeiss Meditec AG (Jena); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): Carl Zeiss Meditec AG (Jena); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; +1(925)216-4697
• MDR Report Key: 50870477
• Report Number: 9615030-2026-00026
• Device Sequence Number: 10715684
• Product Code: LZS
• UDI-Device Identifier: 04049471095074
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P060004 S010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Catalogue Number: 000000-2179-684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown