MAUDE Adverse Event Report: CUTERA, INC. ENLIGHTEN III; POWERED LASER SURGICAL INSTRUMENT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Eye Injury (1845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Cutera, inc., received a report from a clinic indicating that a laser technician sustained an ocular injury ("pupil burn") during a tattoo removal procedure involving the enlighten iii laser system and an unspecified "patch." according to the clinic, the technician was struck in the eye by a laser beam "that reflected off the patch" and was not wearing protective eyewear at the time of the incident.Following the injury, the technician was referred to a specialist and diagnosed with a burn to the pupil.Based on the information provided, the incident appears to involve operator error, specifically the failure to use appropriate eye protection as required by the enlighten iii instructions for use (ifu).The clinic reported that the laser beam reflected off the "patch" used during the procedure; however, no additional information regarding the brand or specifications of the patch was provided.The enlighten iii ifu includes explicit warnings regarding the critical importance of protective eyewear for all individuals present during laser operation.However, the ifu does not address the use of third-party patches in conjunction with the enlighten iii laser system.There has been no indication of enlighten iii laser system malfunction or failure.To date, cutera has not received any other reports of eye injuries occurring when the recommended protective eyewear was used correctly.The event was most likely the result of user non-compliance with standard laser safety protocols.The absence of protective eyewear and the use of an unverified third-party patch may have contributed to the reflection and subsequent injury.Cutera has taken the following actions in response to this event: - issued a formal response to the clinic reiterating the importance of using procedure-appropriate protective eyewear.- provided a summary of eye hazards associated with class iv medical lasers and precautions for injury prevention.- recommended review of ansi z136.3 - american national standard for safe use of lasers in health care facilities.- supplied links to certified laser safety training courses tailored to medical professionals.- shared the enlighten iii operator manual and treatment guidelines, emphasizing sections related to protective eyewear and safety protocols.- offered a clinical education session with cutera's clinical applications specialists to review selection of protective eyewear.- advised the clinic to report the incident to the manufacturer of the patch used during the procedure.The clinic did not disclose the date of the procedure, nor has it provided any supplemental details beyond the initial incident report submitted to cutera.This medical device report is being filed in good faith based solely on the limited information available from the clinic at the time of reporting.

• Brand Name: ENLIGHTEN III
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005
• MDR Report Key: 22081619
• Report Number: 2954354-2025-00003
• Device Sequence Number: 12496482
• Product Code: GEX
• UDI-Device Identifier: 00816722021649
• UDI-Public: 010081672202164911171009
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182997
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: Other
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2017
• 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; Required Intervention
• Patient Sex: Female