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

Model Number	BL11110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in japan reported that during cataract surgery the irrigation pressure was too high and after inserting the handpiece the capsule ruptured.The system was switched out to a different manufacturer and a vitrectomy was completed.Additional information was requested but not received.
Additional Manufacturer Narrative
The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
A field service engineer serviced the unit and no issue was found.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: STELLARIS 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, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 23881352
• Report Number: 0001920664-2025-00139
• Device Sequence Number: 20010315
• Product Code: HQC
• UDI-Device Identifier: 00757770480678
• UDI-Public: (01)00757770480678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: BL11110
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown