MAUDE Adverse Event Report: LUMENIS BE LTD M22; M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM, PRODUCT CODE: GEX

Model Number	GA-0005200CN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 11/19/2025, lumenis received a report of an adverse event from the nmpa in china regarding a burn suffered by a patient during an m22 dry eye treatment conducted on (b)(6) 2025.The nmpa approved the event report on 11/6/2025."on (b)(6) 2025.4, after the patient was treated for dry eye syndrome with intense pulsed light and laser systems, it was found that there were burns around the eyes." additional text: "after undergoing dry eye treatment with intense pulsed light, it was found that there were burns around the eyes, but the cause could not be determined" a service engineer went onsite and noted the following; "the energy of the hand tool is good, the cooling of the hand tool is normal, add cooling water, and confirm that the functional parameters of the instrument are normal." as the system was found to be functioning as intended (nff) system malfunction has been ruled out.A review of the m22 (model: ga-0005200cn, serial number: (b)(6) dhr records showed that the system was manufactured according to relevant procedures, tested before release and shipped according to specifications.The system manufacturing release date was 2/12/2018 and the installation date was on (b)(6) 2018.A clinical investigation was performed by the (b)(6) clinical director (b)(6) with the following conclusions: severity; 6 - serious injury requiring non-surgical medical treatment analysis; clinical evaluation findings.On (b)(6), a female dry eye patient underwent an opt treatment with the m22 device.The treatment caused a second-degree burn (hyperpigmentation and blisters).Additional findings: after investigation of this case, the hospital reported to us that the operator of the m22 system was not familiar with the parameters, and the original toyos parameter was mistakenly changed to a single pulse instead of a triple pulse (the so-called "toyos protocol").It is not clear what was the fluence used.In one place it was reported that the fluence used was 10 j/cm2, and in another it was reported as 12 j/cm2.The latter fluence seems to be the correct value.In any case, what caused the burn is a user error of using a single pulse of 4 msec, instead of a triple pulse where the energy is spread over several tens of milliseconds.Root cause failure; user error.Root cause; user error.Investigation conclusions: a second-degree burn was caused by a user error, where the operator used a single pulse of 4 msec instead of a triple pulse where the energy should have been spread across several tens of milliseconds.The severity of the burn was rated by the clinical director as 6 - serious injury requiring non-surgical medical treatment.In summary, there was no malfunction with the system and the cause of the burn was determined by the clinical director to be user error.As the severity of the burn was determined to be serious (6), this is reportable to both the fda and to the nmpa.Due to the abovementioned severity of the injury and per the decision tree determination, lumenis will report this event to the fda and also to the chinese authorities as nmpa#: 1335110362025000471.Lumenis will continue to monitor the event and should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.Lumenis is closing this complaint at this time.Complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4) and per post marketing surveillance procedure (doc no.(b)(4).
Event or Problem Description
On (b)(6) 2025.4, after the patient was treated for dry eye syndrome with intense pulsed light and laser systems, it was found that there were burns around the eyes.

• Brand Name: M22
• Common Device Name: M22 FOR INTENSE PULSED LIGHT (IPL) AND LASER SYSTEM, PRODUCT CODE: GEX
• Manufacturer (Section D): LUMENIS BE LTD; 9 hakidma st; po box 426; yokneam, 20692 36; IS 2069236
• Manufacturer (Section G): LUMENIS BE LTD; 9 hakidma st; po box 426; yokneam, 20692 36; IS 2069236
• Manufacturer Contact: yossi avnilov ; 9 hakidma st; po box 426; yokneam, 20692-36 ; IS 2069236
• MDR Report Key: 23800393
• Report Number: 3021349626-2025-00012
• Device Sequence Number: 21172227
• Product Code: GEX
• UDI-Device Identifier: 07290109140360
• UDI-Public: 07290109140360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GA-0005200CN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: Asian