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

Model Number	BL11114
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time when the system had this problem and later, they (b+l engineers) were not contacted, nor did they go to repair it; the distributor engineers were also not informed of the event.So, there was no service report.The system was restarted and resumed normal use on the same day of the event.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.Based on the available information, the root cause could not be confirmed due to lack of returned product or service investigation.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.
Event or Problem Description
The china national device adverse event reporting system submitted this report where there was a posterior capsule rupture during cataract surgery.There was a sudden loss of infusion during surgery (infusion fluid is present) causing the patient's anterior chamber to collapse and the posterior capsule to rupture.The vitreous was partially removed and an intraocular lens was implanted in the ciliary sulcus.The patient's condition was temporarily stabilized.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22609246
• Report Number: 0001920664-2025-00090
• Device Sequence Number: 21266725
• Product Code: HQC
• UDI-Device Identifier: 00757770520190
• UDI-Public: (01)00757770520190(11)201123
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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: BL11114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2020
• 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 Age: 52 YR
• Patient Sex: Male