LightSheer DuetRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07290109140483), received between Jan 17, 2019 and Jul 23, 2025 — classified as 28 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Burn(s)

  MAUDE report 22573860 ↗
• InjuryJul 25, 2023Calibration Problem; Calibration Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN ON LEGS FOLLOWING TREATMENT BY LIGHTSHEER DUET DEVICE. PER THE CUSTOMER, THERE WERE ERRORS E141, E81 AND E83 POPPED UP. NO INCIDENT FORM OR PATIENT PHOTO RECEIVED IN LUMENIS.

  Patient problems: Burn(s)

  MAUDE report 17387493 ↗
• InjuryApr 28, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT SEVERAL PATIENTS SUSTAINED BURN OF UNKNOWN SEVERITY TO THE FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER DUET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THE COMPLAINT REPRESENTS ALL PATIENTS AS LUMENIS RECEIVED ONLY ONE INCIDENT FORM.

  Patient problems: Burn(s)

  MAUDE report 14236049 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT FOLLOWING TREATMENT BY HS HP ON LIGHTSHEER DUET DEVICE. REPORTED BY CUSTOMER THAT THE HS HP IS RUNNING HOT. NO ABNORMAL FUNCTIONALITY WITH SMALL HP AND WHEN DISCONNECTING THE HP THEY NOTICES A LOT OF LINT/DUST.

  Patient problems: Burn(s)

  MAUDE report 12300598 ↗
• MalfunctionNov 30, 2020Adverse 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 MARKS FOLLOWING TREATMENT WITH A LIGHTSHEER DUET DEVICE. REPORTED THAT WHILE USING THE HS HANDPIECE A HOLE WAS MADE TO THE SIDE OF THE TIP AND THAT MESSAGE APPEARED REGARDING THE HANDPIECE NOT BEING CONNECTED/RECOGNIZED.

  Patient problems: Pain

  MAUDE report 10923255 ↗
• InjuryNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN DISTRIBUTOR REPORTED ON TWO (3) PATIENTS SUSTAINED BURNS FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER DUET HSET. THIS PATIENT SUSTAINED A BURN TO THE LEGS. THIS COMPLAINT REPRESENTS ALL 3 PATIENTS AS NO INCIDENT FORMS RECEIVED.

  Patient problems: Burn(s)

  MAUDE report 10841519 ↗
• InjuryOct 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A FOREIGN DISTRIBUTOR REPORTED THAT THEIR CUSTOMER WAS CLAIMING SEVERAL CASES OF BURN DURING VASCULAR TREATMENT WITH A LUMENIS LIGHTSHEER DEVICE. NO REPORT ON A SERIOUS INJURY WAS RECEIVED. THE ORIGINAL MAIL FROM THE DISTRIBUTOR TO THE EU NDC REPRESENTATIVE ((B)(6)) MENTIONED SEVERAL OTHER ISSUES AT OTHER SITES AS WELL, HOWEVER, MR. (B)(6) INDICATED THAT THE OTHER ISSUES WERE JUST TECHNICAL QUESTIONS WHICH HE ANSWERED AND THAT THERE WERE ONLY 3 ACTUAL COMPLAINTS ON SPLENDOR X SYSTEMS AT 3 DIFFERENT SITES AND THIS COMPLAINT ON A LIGHTSHEER SYSTEM AT A SEPARATE SITE. THUS 4 PC'S WERE OPENED, ONE FOR EACH SITE AND CASE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 10688597 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT WHILE USING LIGHTSHEER DUET, THE SYSTEM BURNED PATIENT.

  Patient problems: Burn(s)

  MAUDE report 10337230 ↗
• InjuryJun 8, 2020Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A FOREIGN FACILITY REPORTED THAT DURING A PROCEDURE WITH LIGHTSHEER DUET A PATIENT WAS BURNT. THE FACILITY REPORTED ON COOLING PROBLEMS.

  Patient problems: Burn(s)

  MAUDE report 10127939 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT TWO (2) PATIENT SUSTAINED AN INJURY FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER LASER.

  Patient problems: Burn(s)

  MAUDE report 9961244 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY FOLLOWING TREATMENT WITH LIGHTSHEER DUET LASER.

  Patient problems: Burn(s)

  MAUDE report 9932139 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN INITIAL REPORT INVOLVING A LAWSUIT AGAINST (B)(6) FOLLOWING TREATMENT WITH A REFURBISHED LIGHTSHEER DUET. THE REPORT WAS ON AN ALLEGED INJURY TO A PATIENT. NO INFORMATION ON THE SEVERITY OR DATE OF THE EVENT WAS RECEIVED.

  Patient problems: Burn(s)

  MAUDE report 9837431 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN USER FACILITY REPORTED THAT AFTER TREATMENT WITH LIGHTSHEER ET A PATIENT WAS BURNED WITH SMALL RED DOTS.

  Patient problems: Burn(s)

  MAUDE report 9804493 ↗
• InjuryJan 26, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN FACILITY REPORTED THAT A PATIENT GOT BURNED AFTER TREATMENT WITH LIGHTSHEER DUET.

  Patient problems: Burn(s)

  MAUDE report 9630432 ↗
• MalfunctionOct 22, 2019Connection Problem; Connection Problem

  A USER FACILITY REPORTED THAT THREE (3) PATIENTS SUSTAINED BURNS FOLLOWING HAIR REMOVAL TREATMENT PROCEDURES WITH A LUMENIS LIGHTSHEER DUET HS/ET LASER. THIS COMPLAINT IS FOR PATIENT 3 OF 3 (FIRST DEGREE BURN).

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9217272 ↗
• MalfunctionOct 21, 2019Connection Problem; Connection Problem

  A USER FACILITY REPORTED THAT THREE (3) PATIENTS SUSTAINED BURNS FOLLOWING HAIR REMOVAL TREATMENT PROCEDURES WITH A LUMENIS LIGHTSHEER DUET HS/ET LASER. THIS REPORT IS FOR PATIENT 1 OF 3.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9213571 ↗
• MalfunctionOct 21, 2019Connection Problem; Connection Problem

  A USER FACILITY REPORTED THAT THREE (3) PATIENTS SUSTAINED BURNS FOLLOWING HAIR REMOVAL TREATMENT PROCEDURES WITH A LUMENIS LIGHTSHEER DUET HS/ET LASER. THIS COMPLAINT IS FOR PATIENT 2 OF 3

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 9213569 ↗
• InjuryOct 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN USER FACILITY REPORTED TO CLARION ON ONE (1) PATIENT WHO SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN AREA FOLLOWING TREATMENT WITH LIGHTSHEER DUET HS/ET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM CLARION.

  Patient problems: Burn(s)

  MAUDE report 9211937 ↗
• InjuryOct 3, 2019Calibration Problem; Calibration Problem

  A FOREIGN USER FACILITY REPORTED THAT 9 PATIENTS SUFFERED FROM BURNS FOLLOWING HAIR REMOVAL TREATMENT PROCEDURES WITH A LUMENIS LIGHTSHEER DUET HS/ET LASER. PATIENT AMN - 7 OF 9. CHIN AND UPPER LIP.

  Patient problems: Burn(s)

  MAUDE report 9150123 ↗
• InjuryOct 3, 2019Calibration Problem; Calibration Problem

  A FOREIGN USER FACILITY REPORTED THAT 9 PATIENTS SUFFERED FROM BURNS FOLLOWING HAIR REMOVAL TREATMENT PROCEDURES WITH A LUMENIS LIGHTSHEER DUET HS/ET LASER.

  Patient problems: Burn(s)

  MAUDE report 9150078 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT SEVERAL PATIENTS SUSTAINED BURN OF UNKNOWN SEVERITY TO THE FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER DUET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THE COMPLAINT REPRESENTS ALL PATIENTS AS LUMENIS RECEIVED ONLY ONE INCIDENT FORM.

  Patient problems: Burn(s)

  MAUDE report 9108326 ↗
• InjuryJun 27, 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 OF UNKNOWN SEVERITY TO AN UNKNOWN BODY PART FOLLOWING TREATMENT WITH LUMENIS LIGHTSHEER DUET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8738660 ↗
• MalfunctionMay 30, 2019Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED A USER SUBMITTED MEDWATCH REPORT INVOLVING USE OF A LIGHTSHEER DUET. THE EVENT DESCRIPTION READS, "PATIENT PRESENTED TO DERMATOLOGY CLINIC FOR ELECTIVE LASER HAIR REMOVAL TO UPPER LIP, CHIN, BEARD AREA, AXILLA, ARM-ELBOW TO HAND, SHOULDER TO ELBOW, AND THIGHS TO LOWER LEG. THREE (3) DAYS POST-PROCEDURE PATIENT NOTED TO HAVE SOME BLEEDING AND SLOUGHING TO UPPER LIP. NO UNDERLYING BLISTERS NOTED. PATIENT AREAS APPEARED SUPERFICIAL AND ONLY OCCURRED IN A FEW AREAS. PATIENT EDUCATED TO APPLY AQUAPHOR TO KEEP MOISTURIZED. LASER WAS CALIBRATED AND REPORT WAS NORMAL. LASER REP WAS CALLED IN AND MACHINE INSPECTED. EQUIPMENT NOTED TO BE CRACKED. LASER TAKEN OUT OF SERVICE FOR REPAIR."

  Patient problems: Burn(s)

  MAUDE report 8655706 ↗
• InjuryMay 2, 2019Use of Device Problem; Use of Device Problem

  A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED BURN AROUND THE LIPS, FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER DUET HS/ET. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 8572231 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOREIGN USER FACILITY REPORTED ON A FEW PATIENTS WHO SUSTAINED A BURN OF UNKNOWN SEVERITY TO AN UNKNOWN ANATOMICAL AREA FOLLOWING TREATMENT WITH A LIGHTSHEER DUET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION HAS BEEN RECEIVED EXCEPT FOR THE INITIAL REPORT FROM THE USER FACILITY. THIS COMPLAINT REPRESENTS ALL PATIENTS AS NO INFORMATION WAS RECEIVED BY THE FACILITY ON THE PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 8564619 ↗