LightSheer QUATTRORecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290109144658), received between Jul 21, 2021 and Jul 13, 2023 — classified as 8 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURNS FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE.

  Patient problems: Burn(s)

  MAUDE report 17314504 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LSQ DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16642471 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON PATIENTS WHO SUSTAINED INJURY FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16443158 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENTS WHO SUSTAINED BURNS FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16310235 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE. AN ADVERSE EVENT REPORTED TO SHIA (CLINICAL), BUT NO OTHER DETAILS REPORTED AS OF YET.

  Patient problems: Burn(s)

  MAUDE report 14451913 ↗
• InjuryMay 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE. AN ADVERSE EVENT REPORTED TO (B)(6) (CLINICAL), BUT NO OTHER DETAILS REPORTED AS OF YET.

  Patient problems: Burn(s)

  MAUDE report 14403813 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE.

  Patient problems: Burn(s)

  MAUDE report 13152192 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY LIGHTSHEER QUATTRO DEVICE.

  Patient problems: Burn(s)

  MAUDE report 12201318 ↗