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

Model Number	BL11145
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical support specialist provided this information: according to the doctor, wound edema happened to other registrars that used her settings.This information could not be verified when the sales rep was onsite as the registrar onsite didn¿t confirm her claim.They have reverted to pulsed settings, and during the rep¿s onsite visit, no issues were observed.The rep explained that the majority of energy is used during sculpting, and even when the energy is maximized during segment removal, it is capped at 30%.The doctor consistently uses low levels of phaco power (<10) in the cases the rep observed.The rep asked the surgeon to keep us informed should any further issues arise.The nurse mentioned that new staff have recently joined the cssd team.Since then the rep has spoken with the site to explore whether additional education on phaco handpiece cleaning may be necessary for the new cssd personnel.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
Event or Problem Description
The user facility in australia reported a wound burn.They suspected the phaco modulation introduced on the (b)(6) was the problem (vacuum 100-460, bh 50, bip 15, u/s power 30, fixed pulse waveform pd 600 pi 2) the wound was closed with 4-5 sutures.The patients vision is fine.
Additional Manufacturer Narrative
There was no definite conclusion.The doctor doesn't believe it was related to the machine.The comment came from the fellow after using the new settings.Since we reverted to the old settings using pulsed mode, the fellow has been fine.Use of non-standard/new settings (user technique/configuration).The issue was reported after adopting new settings; no device fault identified by the doctor; symptoms resolved and have not recurred after reverting to prior pulsed-mode settings.The device history was reviewed and found to meet manufacturing specifications.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.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22778087
• Report Number: 0001920664-2025-00094
• Device Sequence Number: 13053203
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)230615
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown