MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT PHACOEMULSIFICATION

Model Number	BL3170
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a wound burn at the main incision port during sculpt where 1x 10-0 vicryl was used to close.Bl3420s is the phaco tip and was disposed and isn¿t available for return.The doctor stated, it could have been a clogged tip but was not certain.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.Related to 1920664-2025-00134.
Additional Manufacturer Narrative
One bl3170 stellaris handpiece, serial number (b)(6) was returned.Visual inspection found the wires twisted inside the cable jacket and the lemo connector casing bent.The needle and the rest of the pack components used were not returned.A functional test was performed using a stellaris system and a known good needle tip.The handpiece tuned, primed, and functioned as intended.The handpiece had good ultrasound and good flow through the needle tip.Additionally, the handpiece was run at 100% power for one full minute without irrigation or aspiration hook-up.The handpiece did not get hot during testing.It cannot be determined if the needle tip used was clogged at the time of customer use.The phaco tip identified by the physician as a possible contributing factor was disposed of and unavailable for analysis, preventing confirmation of a clog or obstruction at the time of use.As a result, the root cause of the complaint remains undetermined due to insufficient evidence and the inability to evaluate the implicated consumable component.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Related to medwatch 1920664-2025-00134.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23958121
• Report Number: 0001920664-2025-00135
• Device Sequence Number: 5610322
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: BL3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND BL3420S NEEDLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown