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	Unspecified Respiratory Problem (4464)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related reports: 9615030-2026-00003, 9615030-2026-00004, 9615030-2026-00005, 9615030-2026-00006, 9615030-2026-00007, 9615030-2026-00008, 9615030-2026-00009, 9615030-2026-00010, 9615030-2026-00011.
Event or Problem Description
Customer in china reported an abnormal smell from the mel 90 device.The mel 90 equipment at the customer's site experienced a leakage of excimer gas due to a malfunction of the solenoid valve.Ten people were in the room at the time of the incident and the affected individuals experienced throat and respiratory discomfort, further medical examinations were conducted.The event may have jeopardized the involved people and may have required medical or surgical intervention (treatment) to address these symptoms.A serious medically important event occurred because of exposure to the gas.

• 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 ; 9252164697
• MDR Report Key: 24171436
• Report Number: 9615030-2026-00002
• Device Sequence Number: 18554191
• Product Code: LZS
• UDI-Device Identifier: 04049471095074
• UDI-Public: (01)04049471095074(11)221201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P060004 S006
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: 000000-2179-684
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown