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

Model Number	BL3170
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product was not returned for evaluation.A review of the device history records found no abnormalities.The investigation is ongoing.
Event or Problem Description
A user facility in france reported that a milky liquid was released from the handpiece.The ultrasound and suction was faulty.The handpiece was changed and the procedure continued.There was no reported patient impact.
Additional Manufacturer Narrative
The handpiece was returned and evaluated.The handpiece was evaluated with a bent needle attached and the nose cone was dented.A separation or gap between the connector strain relief and the cable jacket was observed, this created a pathway for moisture ingress.A white crystal-like dried solution was visible in the thread of the nose cone.Using hplc grade water the irrigation tube on the handpiece was flushed into a petri-dish using a clean syringe.The fluid was captured and microscopically examined, there was clear with no visible milky substance in it.The needle had some marring on the flats of the hub, there was discoloration around the tip of the needle.There was a visible dried solution all over the needle and the needle was bent at the tip of the hub.Functional testing was performed with a known good tip, and it tuned, primed, irrigated, and aspirated as it should.The solution was poured into a 0.45-micron filter and vacuumed off in an attempt to trap any substance.It was microscopically examined and there were some dark colored and fiber like particles, however there was no milky substance.The lot history, trend analysis, risk analysis and /or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is complete.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20557623
• Report Number: 0001920664-2024-00137
• Device Sequence Number: 8866101
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)230223
• Combination Product (Y/N): N
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown