MEL 90 1900-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04049471095074), received between Jan 23, 2026 and Sep 23, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Gas/Air Leak

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870477 ↗
• MalfunctionFeb 2, 2026Gas/Air Leak

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239763 ↗
• MalfunctionFeb 2, 2026Gas/Air Leak

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235382 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172925 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172874 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172773 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172747 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172499 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172367 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172270 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24172043 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24171757 ↗
• InjuryJan 23, 2026Gas/Air Leak

  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.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24171436 ↗