Opus System 110VRecalls & reported problems
Alma Lasers Ltd. · Class 2
- Adverse event reports
- 24
- Deaths reported
- 1
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 17290110121782), received between Apr 8, 2021 and Jul 29, 2026 — classified as 1 death, 23 injuries.
The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Incorrect Control/Treatment Settings13
- Adverse Event Without Identified Device or Use Problem10
- Device Handling Problem1
- Use of Device Problem1
Patient problems
- Burn(s)9
- Hyperpigmentation8
- Scar Tissue7
- Blurred Vision2
- Eye Pain2
- Swelling/ Edema2
- Eye Injury1
- Insufficient Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Use of Incorrect Control/Treatment Settings
The importer reported that user facility reported that a patient sustained burns at the treatment sites following use of the Opus System.
Patient problems: Burn(s)
MAUDE report 50066663 ↗InjuryJul 27, 2026Use of Incorrect Control/Treatment Settings
A user facility reported that a patient sustained burns at the treatment sites following use of the Opus System. Alma Lasers Inc. conducted an investigation and requested the Opus System used during treatment for evaluation. Upon inspection the device was found to have met manufacturers' specifications. The invesitgation also included a clinical evaluation, which determined that the event was most likely attributable to user technique. However, as the injury is expected to result in scarring, this event is being reported in good faith.
Patient problems: Burn(s)
MAUDE report 50010302 ↗InjuryMay 18, 2026Use of Incorrect Control/Treatment Settings
IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE OPUS SYSTEM.
Patient problems: Burn(s)
MAUDE report 25197161 ↗InjuryMay 12, 2026Use of Incorrect Control/Treatment Settings
A USER FACILITY REPORTED THAT A PATIENT SUSTAINED A BURN AT THE TREATMENT SITE FOLLOWING USE OF THE OPUS SYSTEM. ALMA LASERS INC. CONDUCTED AN INVESTIGATION AND DETERMINED THAT THE EVENT WAS MOST LIKELY ATTRIBUTABLE TO USER TECHNIQUE. HOWEVER, AS THE INJURY IS EXPECTED TO RESULT IN SCARRING, THIS EVENT IS BEING REPORTED IN GOOD FAITH. THE DEVICE WAS REQUESTED FOR EVALUATION; HOWEVER, DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS BY ALMA LASERS INC. TO COORDINATE DEVICE RETRIEVAL, THE CUSTOMER HAS NOT RESPONDED.
Patient problems: Burn(s)
MAUDE report 25151394 ↗InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED HYPERPIGMENTATION IN THE TREATMENT AREA FOLLOWING THE USE OF THE OPUS SYSTEM.
Patient problems: Hyperpigmentation
MAUDE report 22984221 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED EYE PAIN AND BLURRED VISION APPROXIMATELY THIRTY MINUTES AFTER LEAVING THE FACILITY, WHERE SHE HAD UNDERGONE TREATMENT WITH THE OPUS SYSTEM. ACCORDING TO THE REPORT, THE PATIENT SUBSEQUENTLY VISITED AN EMERGENCY DEPARTMENT AND WAS TREATED WITH EYE DROPS, WHICH RESOLVED HER SYMPTOMS WITHIN 48 HOURS. NO DIAGNOSTIC INFORMATION WAS PROVIDED BY THE ATTENDING OPHTHALMOLOGIST; THEREFORE, A DIRECT CAUSAL RELATIONSHIP BETWEEN THE REPORTED SYMPTOMS AND THE OPUS SYSTEM COULD NOT BE ESTABLISHED. NONETHELESS, THIS REPORT IS BEING SUBMITTED IN GOOD FAITH.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 22748655 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED EYE PAIN AND BLURRED VISION APPROXIMATELY THIRTY MINUTES AFTER LEAVING THE FACILITY, WHERE SHE HAD UNDERGONE TREATMENT WITH THE OPUS SYSTEM. ACCORDING TO THE REPORT, THE PATIENT SUBSEQUENTLY VISITED AN EMERGENCY DEPARTMENT AND WAS TREATED WITH EYE DROPS, WHICH RESOLVED HER SYMPTOMS WITHIN 48 HOURS. NO DIAGNOSTIC INFORMATION WAS PROVIDED BY THE ATTENDING OPHTHALMOLOGIST; THEREFORE, A DIRECT CAUSAL RELATIONSHIP BETWEEN THE REPORTED SYMPTOMS AND THE OPUS SYSTEM COULD NOT BE ESTABLISHED. NONETHELESS, THIS REPORT IS BEING SUBMITTED IN GOOD FAITH.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 22484489 ↗InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT DEVELOPED A FACIAL SWELLING AT THE TREATMENT SITE FOLLOWING USE OF THE OPUS SYSTEM. AS A RESULT, THE USER FACILITY ALLEGED THAT THE PATIENT EXPERIENCED AN AIRWAY COMPROMISE WHICH REQUIRED EMERGANCY MEDICAL ATTENTION AND STEROIDS FOR TREATMENT.
Patient problems: Swelling/ Edema
MAUDE report 22080519 ↗InjuryMay 23, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
THE IMPORTER REPORTED THAT USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AT THE TREATMENT SITE FOLLOWING USE OF THE OPUS SYSTEM.
Patient problems: Burn(s)
MAUDE report 22078005 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY REPORTED THAT A PATIENT DEVELOPED FACIAL SWELLING AT THE TREATMENT SITE FOLLOWING THE USE OF THE OPUS SYSTEM. AS A RESULT, THE USER FACILITY ALLEGED THAT THE PATIENT EXPERIENCED AIRWAY COMPROMISE WHICH REQUIRED EMERGENCY MEDICAL ATTENTION AND STEROIDS FOR TREATMENT.
Patient problems: Swelling/ Edema
MAUDE report 21913929 ↗InjuryApr 25, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BURNS AT THE TREATMENT SITE FOLLOWING THE USE OF THE OPUS SYSTEM.
Patient problems: Burn(s)
MAUDE report 21913541 ↗InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ABOUT HYPERPIGMENTATION FOLLOWING THE OPUS PLASMA TREATMENT.
Patient problems: Hyperpigmentation
MAUDE report 19653251 ↗InjuryJun 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ABOUT IDENTATIONS FOLLOWING THE OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation
MAUDE report 19591680 ↗InjuryApr 23, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A HYPERPIGMENTATION AND A SCAR FOLLOWING THE OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation; Scar Tissue
MAUDE report 19163816 ↗InjuryApr 23, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A HYPERPIGMENTATION AND A SCAR FOLLOWING THE OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation; Scar Tissue
MAUDE report 19163694 ↗InjuryApr 22, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A HYPERPIGMENTATION AND A SCAR AROUND BOTH EYES FOLLOWING THE OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation; Scar Tissue
MAUDE report 19157365 ↗InjuryApr 18, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A HYPERPIGMENTATION AND A SCAR FOLLOWING THE OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation; Scar Tissue
MAUDE report 19131610 ↗InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ABOUT A HYPERPIGMENTATION POST-OPUS COLIBRI TREATMENT.
Patient problems: Hyperpigmentation
MAUDE report 18713024 ↗InjuryJan 9, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED ABOUT A BURN AND HYPERPIGMENTATION AFTER OPUS PLASMA TREATMENT.
Patient problems: Burn(s)
MAUDE report 18472629 ↗InjuryJan 1, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT SCARRING FOLLOWING THE OPUS TREATMENT.
Patient problems: Scar Tissue
MAUDE report 18423100 ↗InjuryDec 25, 2023Use of Incorrect Control/Treatment Settings; Device Handling Problem; Use of Incorrect Control/Treatment Settings; Device Handling Problem
IT WAS REPORTED ABOUT A BURN AND POSSIBLE SCAR FOLLOWING OPUS PLASMA TREATMENT.
Patient problems: Burn(s); Scar Tissue
MAUDE report 18390450 ↗InjuryDec 25, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
IT WAS REPORTED ABOUT A BURN FOLLOWING THE OPUS PLASMA TREATMENT.
Patient problems: Burn(s); Scar Tissue
MAUDE report 18390441 ↗DeathNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 16-NOV-23 IT WAS REPORTED TO ALMA LASERS LTD ABOUT PATIENT DEATH THAT WAS LIKELY CAUSED BY A BLOOD CLOT. THE IMPORTER HAD INFORMED THAT THE PATIENT RECEIVED AN OPUS PLASMA TREATMENT 4 DAY PRIOR SHE PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 18196484 ↗InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER FACIAL TREATMENT THE PATIENT EXPERIENCED BLURRINESS IN THE RIGHT EYE.
Patient problems: Eye Injury
MAUDE report 11634579 ↗
Other Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat devices
- CHATTANOOGA 27335Djo, LLC · Ultrasonic diathermy for use in applying therapeutic deep heat6 reports
- CHATTANOOGA 27383Djo, LLC · Ultrasonic diathermy for use in applying therapeutic deep heat1 report
- CHATTANOOGA 2782Djo, LLC · Ultrasonic diathermy for use in applying therapeutic deep heat1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.