LightSheer® Desire LightSheer DesireRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07290109140384), received between Jan 20, 2019 and Oct 19, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Calibrate” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BURNS USING HS HANDPIECE FOLLOWING TREATMENT BY LIGHTSHEER DESIRE DEVICE. SINCE NO INCIDENT FORM RECEIVED IN LUMENIS, THIS COMPLAINT WILL REPRESENT ALL INJURED PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 23333910 ↗
• InjuryDec 14, 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 LS DUET DEVICE.

  Patient problems: Burn(s)

  MAUDE report 15975595 ↗
• InjuryDec 5, 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 LS DUET DEVICE..

  Patient problems: Burn(s)

  MAUDE report 15914068 ↗
• InjuryNov 15, 2021Break; Calibration Problem; Break; Calibration Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON PHYSICIAN AND TWO PATIENTS WHO SUSTAINED BURNS FOLLOWING TREATMENT BY LIGHTSHEER DESIRE LASER SYSTEM_GA-1170000:(B)(4) DEVICE. THE CUSTOMER REPORTED, THAT DEVICE STOPS AFTER THREE PULSES AND PHYSICIAN BURNED HERSELF AND TWO MORE PEOPLE GOT BURNED AS WELL. THEY ALSO REPORTED TECHNICAL ISSUES: SOME SCREWS CAME OFF FROM THE BACK PANEL WHERE THE POWER CORD AND INTERLOCK PLUG ARE LOCATED.

  Patient problems: Burn(s)

  MAUDE report 12809780 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED THAT PRIOR TO LAST WEEK WHEN A PATIENT GOT BURNED ON THE SECOND HALF OF THEIR TREATMENT THEY HAD GOT ERROR MESSAGES REGARDING DIODE CURRENT LOW AND TEMP OUT OF RANGE. THEY JUST ACKNOWLEDGED IT AND PROCEEDED TO USE THE SYSTEM. THE PATIENT WAS BEING ON THEIR ARMS AND CHEST, THEY WERE BURNED ON BOTH ARMS. NOT SURE WHICH HP THIS OCCURRED WITH.

  Patient problems: Burn(s)

  MAUDE report 12553958 ↗
• MalfunctionApr 6, 2021Failure to Calibrate; Failure to Calibrate

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON TWO PATIENTS WHO SUSTAINED BURNS AT THE BIKINI AND UPPER LEG AREAS FOLLOWING TREATMENT BY LIGHTSHEER DESIRE DEVICE. THIS COMPLAINT REPRESENTS BOTH PATIENTS AS NO PATIENT INCIDENT FORMS WERE SENT.

  Patient problems: Burning Sensation

  MAUDE report 11620803 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON TWO PATIENTS WHO SUSTAINED BURNS ON THE LEG USING ET HANDPIECE FOLLOWING TREATMENT BY LIGHTSHEER DESIRE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 11278763 ↗
• InjuryNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED A REPORT OF A PATIENT COMPLAINING OF WHITE SPOTS IN HIS RIGHT ARMPIT AFTER TREATMENT WITH LIGHTSHEER DESIRE ON (B)(6) 2020 WITHOUT IMMEDIATE ADVERSE EVENT. ON (B)(6) 2020 SHE RETURNED TO HER TREATMENT PROVIDER FOR FOLLOW-UP, DISPLAYING 2 WHITE DROP-LIKE PATCHES SMALLER THAN 1/10TH OF THE LASER SPOT SIZE. THE PATIENT WAS ASKED TO WAIT FOR CLEAR. ON (B)(6) 2020 SHE RETURNED FOR A SECOND FOLLOW-UP, DISPLAYING THE PREVIOUS 2 WHITE DROP-LIKE PATCHES WHICH EXPANDED (X4-5 TIMES) PLUS ADDITIONAL OCCURRENCE OF 3 NEW HYPOPIGMENTED PATCHES. THIS CAUSED THE PATIENT TO PANIC. AT THAT POINT THE CUSTOMER DECIDED TO INFORM THE DISTRIBUTOR ABOUT THE CASE AND THE DISTRIBUTOR OPENED COMPLAINT TO LUMENIS AND A COMPLAINT WAS OPENED UP AT 10/23/2020.

  Patient problems: Skin Discoloration

  MAUDE report 10841522 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT FOLLOWING LIGHTSHEER DESIRE TREATMENT ON A FEW PATIENTS THAT HAVE BEEN BURNED. ONE OF THE PATIENTS HAS BLISTER AND OPEN WOUND WHICH OCCURRED ABOUT 48 HRS BEFORE REPORTING ON SKIN TYPE 4. THE SETTINGS WERE APPROPRIATE DURING THE PROCEDURE. SINCE NO INCIDENT FORMS WERE SENT THIS COMPLAINT REPRESENTS ALL PATIENTS MENTIONED.

  Patient problems: Burn(s)

  MAUDE report 10808490 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT THE LIGHTSHEER DESIRE IS REQUESTING SERVICE BUT NO ABNORMAL FUNCTIONALITY. THE FACILITY WANT TO CONTACT THE CLINICAL AND ADVISED THEY HAD AN ADVERSE EVENT.

  Patient problems: Burn(s)

  MAUDE report 9779038 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED AN ADVERSE EVENT AFTER TREATMENT WITH LIGHTSHEER DESIRE. THE PATIENT WAS BURNT.

  Patient problems: Burn(s)

  MAUDE report 9529158 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN TO THE CHIN FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DESIRE LASER. INCIDENT FORMS WERE SENT BY THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8789026 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SERVICE ENGINEER REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN AREA FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DESIRE LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THE FACILITY REPORTED ON SMALL HP WHICH NEEDS TO BE CALIBRATED. PATIENTS ARE SAYING THAT THE TREATMENTS ARE PAINFUL BY THE TIP IS GETTING HOT.

  Patient problems: Burn(s)

  MAUDE report 8733559 ↗
• InjuryMay 30, 2019Failure to Calibrate; Failure to Calibrate

  CUSTOMER REPORTED THAT THE SYSTEM HAS LEFT MARKS OF THE GRID ON PATIENTS LEGS. NO FURTHER DETAILS IN REGARDS TO THE NUMBER OF PATIENTS OR SEVERITY. THEY MENTIONED THAT THE SYSTEM HAS REQUIRED SERVICE FOR SOME TIME.

  Patient problems: Burn(s)

  MAUDE report 8653550 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED BURN TO THE UPPER AND LOWER LEGS FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER DESIRE LASER. THE REPORTED EVENT OCCURRED IN (B)(6) 2018 BUT WAS REPORTED TO LUMENIS ONLY ON (B)(6) 2019.

  Patient problems: Burn(s)

  MAUDE report 8481937 ↗
• InjuryFeb 10, 2019Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  A USER FACILITY REPORTED THAT TWO (2) PATIENTS SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN ANATOMICAL AREA FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DESIRE LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THIS COMPLAINT REPRESENTS BOTH PATIENTS AS NO INFORMATION WAS RECEIVED AND ONLY ONE MDR IS SUBMITTED.

  Patient problems: Burn(s)

  MAUDE report 8324699 ↗
• InjuryJan 20, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO BIKINI AREA FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DESIRE LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE APPEARANCE OF SCABS A FEW DAYS AFTER THE TREATMENT. THE PATIENT WAS WITH DARKER SKIN.

  Patient problems: Burn(s)

  MAUDE report 8263157 ↗