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	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer in germany 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 magnetic valve.The customer was instructed by phone how to close the gas valve on the gas bottle.The customer was also instructed not to use the device.There was no adverse event and no serious injuries 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: 24235382
• Report Number: 9615030-2026-00012
• Device Sequence Number: 13066654
• Product Code: LZS
• UDI-Device Identifier: 04049471095074
• UDI-Public: (01)04049471095074(11)201101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 000000-2179-684
• 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: 04/26/2024
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• 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