MAUDE Adverse Event Report: INMODE LTD. LUMECCA 580; ONF

Model Number	AS601864A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Uveitis (2122)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not inspected since this is an isolated incident in this clinic.The investigation points to incomplete coverage of the eyes by the protective goggles during treatment.Per latest updates, patient is improving.Retraining has been scheduled for the clinic.
Event or Problem Description
A female patient complained to the clinic about uveitis in one eye 1 day following lumecca 580 treatment on her face, neck and chest.According to the clinic, when treated between the eyebrows, the patient "jumped and said she felt it a little more".According to the patient, she visited an optician who referred her to local hospital where she was prescibed steroid drops for uveitis.
Event or Problem Description
A female patient complained to the clinic about uveitis in one eye 1 day following lumecca 580 treatment on her face, neck and chest.According to the clinic, when treated between the eyebrows, the patient "jumped and said she felt it a little more".According to the patient, she visited an optician who referred her to local hospital where she was prescibed steroid drops for uveitis.
Additional Manufacturer Narrative
The device was not inspected since this is an isolated incident in this clinic.The investigation points to incomplete coverage of the eyes by the protective goggles during treatment.Per latest updates, patient is improving.Retraining has been scheduled for the clinic.23-apr-2026: a follow-up report is submitted with additional information.The clinic received a retraining.Patient has fully recovered.

• Brand Name: LUMECCA 580
• Common Device Name: ONF
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 24341416
• Report Number: 3010511300-2026-01021
• Device Sequence Number: 9962826
• Product Code: ONF
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring,Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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
• Device Model Number: AS601864A
• Device Catalogue Number: AS601864A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: White