MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE POWER SUPPLY MODULE; UNIT, PHACOFRAGMENTATION

Model Number	BL2351
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in australia reported that during a procedure the system shut down.There was no reported patient impact.
Additional Manufacturer Narrative
A field service engineer evaluated the system and revealed a loose connection to the main power cable socket behind the machine.Review of device history record, trend analysis, risk assessment, and directions for use is underway.No remedial, corrective, preventive or field safety corrective action is required.The investigation is ongoing.
Additional Manufacturer Narrative
The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.Based on all available information, the loose connection behind the main power cable caused the system shut down.The investigation is complete.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi is being corrected due to incorrect udi was provided.

• Brand Name: STELLARIS ELITE POWER SUPPLY MODULE
• 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: 18388929
• Report Number: 0001920664-2023-70151
• Device Sequence Number: 14444812
• Product Code: HQC
• UDI-Device Identifier: 00757770524525
• UDI-Public: (01)00757770524525(11)221026
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2023

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: BL2351
• 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; Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/09/2024; 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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