MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) MEL 90; EXCIMER LASER SYSTEM

Catalog Number	000000-2604-691
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At a customer site in india, it was reported that the main valve (magnetic valve close to premix gas cylinder) had a gas leakage and it was observed that the electro magnetic valve had cracks.The o-ring (sealing ring) was replaced, the gas leak arrested.No injury was reported.

• 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: 24239763
• Report Number: 9615030-2026-00013
• Device Sequence Number: 18446624
• Product Code: LZS
• UDI-Device Identifier: 04049471095074
• UDI-Public: (01)04049471095074(11)231001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 000000-2604-691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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