MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL2282
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in france reported that aspiration was lost during the procedure.The patient was moved to a different operation room where another system was used to complete the surgery.The procedure was extended by 55 minutes.Currently, there is no impact on the patient.
Additional Manufacturer Narrative
The system was evaluated by a service engineer and the issue was not duplicated during the test.No error message was observed in the logfile that was related to the reported issue.The external air reduction valve and the air tube from reduction valve to wall plug were preventively replaced.Since then, surgeries have been completed without issues.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.The investigation is ongoing.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Product evaluation did not confirm the failure and we are unable to determine the root cause.No corrective action required.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18364991
• Report Number: 0001920664-2023-70147
• Device Sequence Number: 12766117
• Product Code: HQC
• UDI-Device Identifier: 00757770497836
• UDI-Public: (01)00757770497836
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: BL2282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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: BL2295 IFC03275, BL2364 UPC05211, AND ACCESSORIES.
• Patient Sex: Unknown