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

Model Number	BL11145
Medical Device Problem Code	Failure to Select Signal (1582)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A field service technician at the user facility replaced the foot pedal.The foot pedal was sent to the depot for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Event or Problem Description
It was reported by the user facility that the foot control did not reflux when commanded and caused constant irrigation which did not switch off.The capsule tore causing an anterior vitrectomy to be performed.The surgery was completed, and the patient is fine.
Additional Manufacturer Narrative
Correction to h4 from: 08-feb-2017 to: 19-sep-2017.
Additional Manufacturer Narrative
Depot evaluation reported that the issue was not duplicated during comprehensive functional testing in both wired and wireless modes.The unit met all operational requirements.Although physical damage (cracked laser shroud and center pedal) was observed, it did not affect functionality during evaluation.No systemic failure was identified.The foot control is a high-use, floor-based accessory that is routinely subjected to movement, handling, and environmental exposure during normal operation.This use profile inherently increases the likelihood of wear-related or handling-related complaints.The primary complaint drivers observed include foot pedal functionality concerns, physical damage, and error messages, which are consistent with the intended use environment of a mobile accessory.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.No systemic failure mode or adverse trend has been identified.The product will continue to be monitored.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 24188986
• Report Number: 0001920664-2026-00001
• Device Sequence Number: 15846741
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)170919
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: BL11145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 03/18/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2017
• 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: BL2394 EFC00115.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown