MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. ULTREON¿; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	600132440
Medical Device Problem Codes	Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a contrast bag was placed above the doc holster, and was not properly sealed, which resulted in fluid leakage onto the unit.Burning and smoke from the doc holster was observed by the staff.The system was immediately disconnected with the assistance of the hospital¿s biomedical engineering team to prevent further risk.There was no patient involvement.Field service was completed, and the doc holster was replaced to resolve the issue.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.It was reported that a contrast bag was placed above the doc holster, and was not properly sealed, which resulted in fluid leakage onto the unit.Burning and smoke from the doc holster was observed by the staff.The system was immediately disconnected with the assistance of the hospital¿s biomedical engineering team to prevent further risk.There was no patient involvement.Field service was completed, and the doc holster was replaced to resolve the issue.No additional information was provided.Optis¿ integrated next operation and maintenance manual states mechanical enclosure: warning: do not use the optis integrated next if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing, or the user or patient may be exposed to electrical shock or faulty readings may appear.Contact your supplier for further action.The optisi next doc holster risk assessment report was reviewed and an example of smoking/device emits odor can be found.Factors that may contribute to smoking/device emits odor include but are not limited to liquid ingress causing the system to short.The cause of the reported burning and smoke from the doc holster was most likely due to the user allowing an improperly sealed contrast bag over the doc holster to leak onto the unit resulting in liquid ingress and damage to the electrical components within the doc holster.Product was not returned for evaluation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ULTREON¿
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23706974
• Report Number: 2024168-2025-11853
• Device Sequence Number: 10691710
• Product Code: NQQ
• UDI-Device Identifier: 05415067036810
• UDI-Public: (01)05415067036810(11)240219
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K150237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 600132440
• Device Catalogue Number: 600132440
• Device Lot Number: 10194154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown