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

Model Number	BL11145
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer visited the facility and initial replaced the elite interface computer.After a reoccurrence of the failure, the engineer returned to the site and replaced the power supply and foot control cable to correct the problem.The elite interface computer and power supply are returning for additional evaluation.Elite foot controller bl2394 efc00237 contributed to the system shutdown confirmed due to malfunctioned foot controller cable.Manufacturing and sterilization records for efc00237, elite interface computer bl2365 eic00199, and power supply bl2351 sps09369 were reviewed and found to be acceptable.This investigation is ongoing.Related complaint: 0001920664-2024-00140.
Event or Problem Description
The user facility reported that after the eic was replaced with a new one, the system powered off during a case the next day.No patient impact or intervention reported.
Additional Manufacturer Narrative
The elite interface computer bl2365 eic00199, and power supply bl2351 sps09369 were returned, and evaluation confirmed no problems were found.The root cause was determined to be a defective/malfunctioned foot controller cable on elite foot controller bl2394 efc00237.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates for elite foot controller bl2394 efc00237, elite interface computer bl2365 eic00199, and power supply bl2351 sps09369.No corrective action is required.Correction to h6 investigation findings from: 104 to: 135.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH AND LOMB ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO ; 6362263220
• MDR Report Key: 20770481
• Report Number: 0001920664-2024-00149
• Device Sequence Number: 8004498
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)181108
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 11/05/2024

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: BL11145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2017
• 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: BL2365, BL2394, BL2351.
• Patient Sex: Unknown